Surg Endosc DOI 10.1007/s00464-014-3776-3
and Other Interventional Techniques
Tricks to decrease the suture line dehiscence rate during endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) Alessandro M. Paganini • Andrea Balla • Silvia Quaresima • Giancarlo D’Ambrosio Paolo Bruzzone • Emanuele Lezoche
•
Received: 3 April 2014 / Accepted: 23 July 2014 Ó Springer Science+Business Media New York 2014
Abstract Background ELRR by TEM is a valid alternative to TME in selected patients with early low rectal cancer, with similar long-term oncological results and better Quality of Life. The authors’ policy is to close the residual defect, with possibly a higher risk of dehiscence from tension on the suture line. Aim is to evaluate if a modified technique may reduce the risk of dehiscence. Methods The latest series of 50 patients undergoing ELRR was analyzed and patients were divided in two consecutive groups. In Group A, 25 patients underwent ELRR by TEM with the authors’ standard technique. In Group B, a subsequent series of 25 patients also underwent ELRR, but the perirectal residual cavity was filled with a hemostatic agent prior to rectal wall closure. After suture completion, the rectal ampulla was stuffed with gauzes to avoid the formation of a perirectal fluid collection, by enlarging the volume of the residual rectal ampulla. A transanal Foley catheter was positioned for gas evacuation. Results There were no significant differences in mean tumor distance from the anal verge, mean lesion diameter, mean operative time, and pathological staging between the
Presented at the SAGES 2014 Annual Meeting, April 2–5, 2014, Salt Lake City, Utah. A. M. Paganini A. Balla (&) S. Quaresima G. D’Ambrosio P. Bruzzone E. Lezoche Department of General Surgery, Surgical Specialties and Organ Transplantation ‘‘Paride Stefanini’’, Sapienza University, Rome, Italy e-mail: [email protected] A. M. Paganini e-mail: [email protected]
two groups. Neoadjuvant radio-chemotherapy (n-RCT) in Groups A and B was performed in 6 and 2 patients, respectively. Suture line dehiscence in Group A occurred in 3 patients (12 %) and in group B it was nil. In patients who experienced a dehiscence, mean lesion diameter was 6.3 cm (range 6–7). None of these patients had undergone n-RCT. Conclusion After ELRR by TEM, suture line dehiscence is presumably related to the wider size of the residual cavity. Obliteration of the residual perirectal space with hemostatic agent and by gauzes’ introduction in the rectal ampulla may reduce the risk of postoperative perirectal abscess and thus reduce the suture line dehiscence rate. Keywords Rectal cancer Dehiscence Endoluminal loco-regional resection (ELRR) Transanal endoscopic microsurgery (TEM) Wound separation
The authors have previously described an original surgical technique, endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) [1], for the treatment of low rectal cancer in selected patients, with similar long-term oncological results as compared to laparoscopic total mesorectal excision (LTME) [2, 3]. Quality of life (QoL) evaluation also proved ELRR by TEM to be better than LTME in selected patients [4]. This technique is different from full-thickness local excision by TEM, as proposed by Buess in 1983 [5], because it is aimed at obtaining en bloc resection of the rectal wall with tumor, together with loco-regional mesorectal fat and mesorectal fascia [1–3]. In fact, the deeper level of dissection is carried along the plane of the mesorectal fascia [1–3] and after excision a much larger defect of the rectal wall and in the perirectal space is
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created. The authors’ policy is to close the defect in every patient and thus the size of the residual defect after ELRR may be associated with a higher risk of dehiscence from tension of the suture line. The authors postulated that a possible cause of dehiscence might be related to infection of a fluid collection localized in the perirectal space after suture of the rectal walls. The solution proposed by the authors is to obtain the obliteration of the perirectal space that remains after ELRR. Aim of this study is to evaluate if this modified technique may reduce the risk of dehiscence.
Surgical technique Pre-operative colonic washout and short-term antibiotic prophylaxis were administered in all patients. ELRR by TEM was performed by the same surgeon in every case (E.L.). Before introduction of the TEM rectoscope, irrigation of the rectal lumen with povidone-iodine solution and then with saline was carried out, in order to remove any mucous secretion and neoplastic cells’ spillage. The instrumentation described by Buess and Mentges [6] (Wolf Company, Knittlingen, Germany) was used for ELRR by TEM, as previously reported [1–3].
Materials and methods Mucosa incisional line Out of 129 patients who underwent ELRR by TEM from February 2001 to August 2013, the latest series of 50 patients was analyzed and patients were divided in two consecutive groups. In Group A, 25 consecutive patients (12 males, 13 females, mean age 72.1 years, range 47–88) underwent ELRR by TEM with the conventional technique, as previously reported [1–3]. In Group B, a subsequent series of 25 consecutive patients (16 males, 9 females, mean age 69.2 years, range 35–87) (p = 0.3719), also underwent ELRR by TEM but the perirectal residual cavity was obliterated as described below. Pre-operative patients’ stage is summarized in Table 1. The indications for n-RCT were histologically confirmed well (G1) or moderately well (G2) differentiated adenocarcinoma, T2 and T3 rectal cancers, tumor within 12 cm of anal verge located in the extraperitoneal portion of the rectum, negative lymph nodes (N0) and no signs of systematic, or metastatic disease. The n-RCT protocol was 50.4 Gy in 28 fractions over 5 weeks. The anus, rectum, mesorectum, regional, and iliac lymph nodes were irradiated. Staging of the rectal lesion by means of endoscopy and evaluation of tumor diameter by transanal ultrasonography, MRI, or CT scan, with 3-mm abdominal and pelvic sections and digital examination, was carried out 40 days after completion of radiotherapy.
Table 1 Pre-operative stage Pre-operative stage
Group A (n)
Group B (n)
Benign
4
0
iT0
0
2 (previous polypectomy: invasive cancer)
iTis
1
2
iT1
9
12
iT2
5
8
iT3
6
1
i imaging
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The authors consider it mandatory that a circumferential 1 cm margin of histologically proven normal mucosa is removed en bloc with the neoplasia. To obtain this, the incision line is conducted along the tatoo spots (Spot Endoscopic Marker, GI Supply, Camp Hill, PA, USA) performed by flexible endoscopy at admission. Mobilization of the residual margins In order to facilitate the suture of the rectal walls and to reduce tension on the suture line, a wide dissection at the deeper level of the oral side of the operative field is recommended. This dissection and undermining follows the avascular plane of the mesorectal fascia (the ‘‘Holy Plane’’ described by Heald). Suture To facilitate its subsequent closure, a PDS 2/0 (EthiconÓ Inc. Somerville, New Jersey, USA) stitch is applied at the center of the defect so as to approximate the oral and caudal margins. The proper suture then starts from the right side of the defect, as seen by the operator, and proceeds from right to left by applying several running 2/0 PDS sutures, each one carrying a silver clip applied by the scrub nurse at its end. The length of each suture is seven centimeters. The needle must be introduced through the full thickness of the rectal wall at a distance of 1 cm from each margin and a running suture is then performed. Given the large size of the defect, the suture on the left side of the screen, as seen by the surgeon, is generally the most difficult part of the operation because the suture is performed in the upper part of the operative field. Filling the defect with glue Before applying the last suture in Group B, the perirectal cavity was filled up with two syringes of a hemostatic glue
Surg Endosc
(Floseal, Baxter Healthcare Corporation, Deerfield, Illinois, USA) introduced with a cannula.
Table 2 Results
Filling the rectal ampulla with gauzes At the end of the operation, after removal of the operating rectoscope, the residual rectal ampulla was stuffed with two iodoform gauzes (Luigi Salvadori s.p.a, Florence, Italy) in Group B patients. A transanal Foley catheter is introduced with its tip well above the suture line and its balloon is inflated with 10 cc of water, for postoperative gas evacuation. These are removed after 48 h. Wound dehiscence was defined as minor if it involved less than 50 % and major if this was more than 50 % of the suture line. Patients were then followed up by digital rectal examination, tumor markers’ assay, colonoscopy, pelvic MRI, and total body CT scan every 3 months for the first 3 years and every 6 months for the next 2 years. All data were prospectively collected.
Group A
Group B
p value
Mean age, years (range)
72.1 (47–88)
69.2 (35–87)
0.37
Distance from anal verge, cm (range)
5.9 (1–11)
5.08 (1.5–12)
0.3
Mean lesion diameter, cm (range)
3.7 (1–7)
3.1 (0.5–6)
0.27
Mean operative time, min (range)
161.6 (40–300)
180.2 (90–295)
0.3
Mean specimen volume, cm3 (range)
26.11 (10–40)
28.88 (10–40)
0.59
Mean hospital stay, days (range)
7 (3–13)
8 (5–20)
0.16
Mean follow-up time, months (range)
57.4 (43–89)
26.6 (11–42)
0.0001
Neoadjuvant RadioChemotherapy, n
6
2
0.25
Suture line dehiscence, n (%)
3 (12)
0 (0)
0.23
Table 3 Response to n-RCT
Results Distance from the anal verge and mean diameter of the lesion were 5.9 cm (range 1–11) and 3.7 cm (range 1–7), respectively, in Group A, and 5.08 cm (range 1.5–12) (p = 0.2953) and 3.1 cm (range 0.5–6) (p = 0.2620) in Group B. Mean operative time was 161.6 min (range 40–300) in Group A and 180.2 min (range 90–295) in B (p = 0.2999). Mean specimen volume was 26.11 cm3 (range 10–40) in Group A and 28.88 cm3 in Group B (range 10–40) (p = 0.5839). Mean hospital stay was 7 days (range 3–13) in Group A and 8 days (range 5–20) in Group B (p = 0.1669). Mean follow-up was 57.4 (range 43–89) months in Group A and 26.6 (range 11–42) in Group B (p = 0.0001) (Table 2). Neoadjuvant radio-chemotherapy (n-RCT) was performed in 6 patients in Group A and in 2 patients in Group B (p = 0.25) (Table 3). In twelve iT2 patients n-RCT was not performed because invasive cancer was not proven pre-operatively after endoscopic biopsy. Complete response to n-RCT was observed in 2 out of 6 patients in Group A and in 0 out of 2 patients in Group B. Downstaging was observed in all irradiated patients. Pathological staging (Table 4) was as follows: Group A—low grade dysplasia (1), pTis (4), pT0 (4), pT1 (10), pT2 (4), pT3 (1), carcinoid (1). Group B— moderate dysplasia (1), pTis (7), pT0 (3), pT1 (9), pT2 (3), leiomyoma (1), inflammatory hyperplastic polyp (1). Suture line leakage occurred in 3 patients of Group A (12 %), (1 pT0, 1 pTis, 1 pT1) and in none (0 %) of Group B (p = 0.2347). Fever ([38°C) was observed in 8 patients (32 %) in Group A and in 2 patients (8 %) in Group B
Group A (6 patients)
yT0 (n)
yT1 (n)
yT2 (n)
yT3 (n)
iT2 (n)
1
–
–
–
iT3 (n)
1
1
3
–
Group B (2 patients)
yT0 (n)
yT1 (n)
yT2 (n)
yT3 (n)
iT2 (n)
–
1
–
–
iT3 (n)
–
–
1
–
i imaging, y staging after n-RCT
Table 4 Pathological stage pT stage
Group A: pT(iT)
Group B: pT(iT)
Adenoma
1(4)
1(0)
pTis
4(1)
7(2)
pT0
4(0)
3(2)
pT1
10(9)
9(12)
pT2
4(5)
3(8)
pT3
1(6)
0(1)
Other
1 carcinoide(0)
1 leiomyoma(0) 1 hyperplastic polyp(0)
(p = 0.0738). Mean tumor diameter in the 47 patients without suture line dehiscence was 3.1 cm (range 0.5–7). In group A and B the mean diameter of the tumor in the patients without wound separation was 3.3 cm (range 1–7) and 3.1 cm (range 0.5–6), respectively (p = 0.6670). The mean diameter of the tumor in the three patients with suture line leakage was 6.3 cm (range 6–7). None of these
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patients had undergone n-RCT. Two patients with partial suture line leakage (less than 50 % of the suture line) were treated conservatively with long-term oral antibiotics. One patient experienced a complete wound separation that was treated with a diverting stoma. Patients with suture line leakage underwent rectal endoscopy every 30 days, until wound healing. In the two patients treated conservatively, complete healing occurred after 30 and 45 days, respectively. The patient with the complete wound separation required 3 months to achieve complete healing.
Discussion Anastomotic leakage after anterior resection of the rectum for colorectal cancer is a frequent and dreaded complication. In the literature, the dehiscence rate ranges between 2 and 23 % [7–10]. Several factors influence the anastomosis leakage rate after radical surgery and the issue is still debated [7–15]. Male patients have higher dehiscence rates, as compared to female patients [11–13], due to greater difficulty in performing the anastomosis in a narrow pelvis [12]. Blood loss also seems to be associated with a higher risk of dehiscence due to ischemia [11, 14, 15]. Open or laparoscopic surgery do not influence the anastomotic leakage rate [16, 17], as well as the use of preoperative mechanical bowel preparation [18, 19]. Neoadjuvant radio-chemotherapy seems not to influence the dehiscence rate [20] and, according to Fujita et al. [7], a diverting stoma should be performed only in male patients with low rectal cancer after n-RCT and after steroids therapy. Moreover, ligation of the inferior mesenteric artery at its origin may increase the risk of anastomotic leakage from devascularization of the colonic side of the anastomosis [7, 13]. Other authors reported that anastomotic leakage is more frequent after low rectal resection in patients with tumors located within 7 cm from the anal verge [21, 22]. During TEM, closure of the residual defect is identical in males and females and the presence of a narrow pelvis does not influence the suture line leakage rate. There is no ligation of the mesenteric artery and devascularization does not occur. Nevertheless, the dehiscence rate after traditional full-thickness TEM is not negligible and in the literature, it ranges between 1 and 20.9 % [23–30] (Table 5). Some authors reported personal series in which the defect after tumor excision was not closed, and in these studies a partial or full-thickness excision was performed [31–33]. In the series of Bignell et al. [31], in 65 out of 262 patients the defect was not closed if the excision did not exceed 2 cm. Pelvic sepsis occurred in 2.7 % (7 patients), with five patients managed with a temporary diverting
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Table 5 Full-thickness and ELRR dehiscence rate in literature Authors, year
Technique
Dehiscence/ patients
Dehiscence rate (%)
Ganai 2006 [23]
Full-thickness
2/144
1
De Graaf 2011 [24]
Full-thickness
3/216
1.4
Allaix 2009 [25]
Full-thickness
5/300
1.6
Haag 2008 [26]
Full-thickness
5/288
1.7
Allaix 2012 [27]
Full-thickness
5/293
1.7
Bretagnol 2007 [28]
Full-thickness
4/200
2
Marks 2009 [29] Marks 2003 [30]
Full-thickness Full-thickness
11/62 9/43
17.7 20.9
Lezoche 2005 [2]
ELRR
8/100
8
Lezoche 2012 [3]
ELRR
6/50
12
Present study, Group A
ELRR
3/25
12
Present study, Group B
ELRR
0/25
0
stoma, but the incidence of this complication did not seem to be related to closure of the defect. According to Bignell et al. [31], pelvic sepsis often occurred in patients with tumor located within 2 cm from the dentate line (6.5 vs 0.5 %, p \ 0.02) due to the absence of mesorectum in the distal rectum. Maslekar et al. [33] prefer not to close the defect, particularly in case of wide full-thickness excision, to avoid the risk of rectal stricture. In their series of 52 patients, the authors report one case of post-procedural intraperitoneal perforation, which required a temporary colostomy, and two cases of rectal stricture [33]. No pelvic sepsis was reported [33]. In the Maslekar series, early endoscopic follow-up performed on 7 patients has shown small areas of exuberant tissue proven to be granulation tissue at histology [33]. This is a common finding after TEM and it must not be interpreted as a local recurrence. In the authors’ series, this was found in many patients within one year after surgery. Another interesting finding at endoscopic follow-up in six patients of the present series was the presence of a rectal ‘‘pseudodiverticulum’’ along the previous suture line. In these patients, the tumor was located posteriorly in three patients and laterally in the other three. Moreover, four out of six patients had tumors larger than five centimeters. According to the authors’ experience, this finding is due to the presence of a ‘‘locus minoris resistentiae’’, as a result of the absence of perirectal fat that was removed with the specimen. The authors believe that this finding is not related to suture line leakage but it is due only to the extent of ELRR resection. In fact the layer of mucosal pseudodiverticulum appeared completely regular and no fistula was detected. Other authors have evaluated the incidence of dehiscence in TEM in relation to n-RCT [29]. Marks et al. [29], reported the only study that analyzed wound complications after TEM, in relation to the use or not of n-RCT. In a
Surg Endosc
series of 43 patients, a dehiscence rate of 25.6 % (11 patients) after n-RCT was observed [29]. According to Marks et al. [29], this could be due to both sides of the anastomosis having been irradiated. However, in the Marks’ series only 1 out of 11 patients (9 %) needed additional surgery (diverting colostomy) to manage this complication, whereas 91 % of the cases were treated conservatively [29]. The authors’ conclusion based on these data was that n-RCT could be considered a relative factor increasing the suture line leakage rate, but it should not be a contraindication to TEM because the dehiscence rate in irradiated patients and its conservative treatment in most cases make the risk acceptable. In the present study wound separation was not observed in irradiated patients. In twelve iT2 patients who did not undergo n-RCT, only 5 patients were discovered to be pT2 at definitive pathology. Pre-operative imaging in this subgroup of patients overestimated the T-stage in 41 % of them. Two out of three patients with dehiscence had acute cardiac ischemia perioperatively, and peripheral hypoperfusion may have been responsible. It should be emphasized that ELRR is different from full-thickness excision in several aspects, including the fact that it involves more tension on the suture line. Standard full-thickness excision does not include the perirectal fat adjacent to the neoplasia and the residual cavity is smaller than after ELRR. In ELRR, instead, a wider excision of the adjacent perirectal fat leaves a residual cavity of considerable size and the suture line may be subject to tension. For this reason, the plane of the mesorectal fascia is undermined on its oral margin, so as to reduce tension on the suture line. However, ELRR by TEM is associated with 8–12 % dehiscence rate [2, 3] (Table 5). The authors have postulated that there may be other mechanisms responsible for the dehiscence. A wider residual cavity is subject to collection of larger amounts of fluids, which may lead to infection. This infected collection may spontaneously drain through the suture line, which in turn may lead to wound separation. The described technical details have reduced the dehiscence rate in this series from 12 to 0 %, which confirmed the postulated hypothesis. According to the authors, the difference in results is not due to greater surgeon experience and skill in the second group. The authors’ clinical experience with TEM and then with ELRR by TEM started in 1992 and more than 300 patients had undergone TEM or ELRR by TEM for rectal adenoma or carcinoma prior to the beginning of this study. The 50 cases who are the object of the present study were collected well over having completed the learning curve and the authors ascribe the difference in results to the change in surgical technique as described here. The present paper shows the safety and effectiveness of a modified ELRR technique to prevent suture line leakage.
In the literature, no study from other centers about ELRR is available, as shown in Table 5. The weakness of this study, however, is the limited number of patients and the fact that this is a retrospective analysis of prospectively collected data. A larger patients’ series and a randomized trial would be required for more definitive results.
Disclosures Prof. Alessandro M. Paganini, Dr. Andrea Balla, Dr. Silvia Quaresima, Dr. Giancarlo D’Ambrosio, Dr. Paolo Bruzzone, Prof. Emanuele Lezoche, have no conflicts of interest or financial ties to disclose.
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and Other Interventional Techniques
Tricks to decrease the suture line dehiscence rate during endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) Alessandro M. Paganini • Andrea Balla • Silvia Quaresima • Giancarlo D’Ambrosio Paolo Bruzzone • Emanuele Lezoche
•
Received: 3 April 2014 / Accepted: 23 July 2014 Ó Springer Science+Business Media New York 2014
Abstract Background ELRR by TEM is a valid alternative to TME in selected patients with early low rectal cancer, with similar long-term oncological results and better Quality of Life. The authors’ policy is to close the residual defect, with possibly a higher risk of dehiscence from tension on the suture line. Aim is to evaluate if a modified technique may reduce the risk of dehiscence. Methods The latest series of 50 patients undergoing ELRR was analyzed and patients were divided in two consecutive groups. In Group A, 25 patients underwent ELRR by TEM with the authors’ standard technique. In Group B, a subsequent series of 25 patients also underwent ELRR, but the perirectal residual cavity was filled with a hemostatic agent prior to rectal wall closure. After suture completion, the rectal ampulla was stuffed with gauzes to avoid the formation of a perirectal fluid collection, by enlarging the volume of the residual rectal ampulla. A transanal Foley catheter was positioned for gas evacuation. Results There were no significant differences in mean tumor distance from the anal verge, mean lesion diameter, mean operative time, and pathological staging between the
Presented at the SAGES 2014 Annual Meeting, April 2–5, 2014, Salt Lake City, Utah. A. M. Paganini A. Balla (&) S. Quaresima G. D’Ambrosio P. Bruzzone E. Lezoche Department of General Surgery, Surgical Specialties and Organ Transplantation ‘‘Paride Stefanini’’, Sapienza University, Rome, Italy e-mail: [email protected] A. M. Paganini e-mail: [email protected]
two groups. Neoadjuvant radio-chemotherapy (n-RCT) in Groups A and B was performed in 6 and 2 patients, respectively. Suture line dehiscence in Group A occurred in 3 patients (12 %) and in group B it was nil. In patients who experienced a dehiscence, mean lesion diameter was 6.3 cm (range 6–7). None of these patients had undergone n-RCT. Conclusion After ELRR by TEM, suture line dehiscence is presumably related to the wider size of the residual cavity. Obliteration of the residual perirectal space with hemostatic agent and by gauzes’ introduction in the rectal ampulla may reduce the risk of postoperative perirectal abscess and thus reduce the suture line dehiscence rate. Keywords Rectal cancer Dehiscence Endoluminal loco-regional resection (ELRR) Transanal endoscopic microsurgery (TEM) Wound separation
The authors have previously described an original surgical technique, endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) [1], for the treatment of low rectal cancer in selected patients, with similar long-term oncological results as compared to laparoscopic total mesorectal excision (LTME) [2, 3]. Quality of life (QoL) evaluation also proved ELRR by TEM to be better than LTME in selected patients [4]. This technique is different from full-thickness local excision by TEM, as proposed by Buess in 1983 [5], because it is aimed at obtaining en bloc resection of the rectal wall with tumor, together with loco-regional mesorectal fat and mesorectal fascia [1–3]. In fact, the deeper level of dissection is carried along the plane of the mesorectal fascia [1–3] and after excision a much larger defect of the rectal wall and in the perirectal space is
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created. The authors’ policy is to close the defect in every patient and thus the size of the residual defect after ELRR may be associated with a higher risk of dehiscence from tension of the suture line. The authors postulated that a possible cause of dehiscence might be related to infection of a fluid collection localized in the perirectal space after suture of the rectal walls. The solution proposed by the authors is to obtain the obliteration of the perirectal space that remains after ELRR. Aim of this study is to evaluate if this modified technique may reduce the risk of dehiscence.
Surgical technique Pre-operative colonic washout and short-term antibiotic prophylaxis were administered in all patients. ELRR by TEM was performed by the same surgeon in every case (E.L.). Before introduction of the TEM rectoscope, irrigation of the rectal lumen with povidone-iodine solution and then with saline was carried out, in order to remove any mucous secretion and neoplastic cells’ spillage. The instrumentation described by Buess and Mentges [6] (Wolf Company, Knittlingen, Germany) was used for ELRR by TEM, as previously reported [1–3].
Materials and methods Mucosa incisional line Out of 129 patients who underwent ELRR by TEM from February 2001 to August 2013, the latest series of 50 patients was analyzed and patients were divided in two consecutive groups. In Group A, 25 consecutive patients (12 males, 13 females, mean age 72.1 years, range 47–88) underwent ELRR by TEM with the conventional technique, as previously reported [1–3]. In Group B, a subsequent series of 25 consecutive patients (16 males, 9 females, mean age 69.2 years, range 35–87) (p = 0.3719), also underwent ELRR by TEM but the perirectal residual cavity was obliterated as described below. Pre-operative patients’ stage is summarized in Table 1. The indications for n-RCT were histologically confirmed well (G1) or moderately well (G2) differentiated adenocarcinoma, T2 and T3 rectal cancers, tumor within 12 cm of anal verge located in the extraperitoneal portion of the rectum, negative lymph nodes (N0) and no signs of systematic, or metastatic disease. The n-RCT protocol was 50.4 Gy in 28 fractions over 5 weeks. The anus, rectum, mesorectum, regional, and iliac lymph nodes were irradiated. Staging of the rectal lesion by means of endoscopy and evaluation of tumor diameter by transanal ultrasonography, MRI, or CT scan, with 3-mm abdominal and pelvic sections and digital examination, was carried out 40 days after completion of radiotherapy.
Table 1 Pre-operative stage Pre-operative stage
Group A (n)
Group B (n)
Benign
4
0
iT0
0
2 (previous polypectomy: invasive cancer)
iTis
1
2
iT1
9
12
iT2
5
8
iT3
6
1
i imaging
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The authors consider it mandatory that a circumferential 1 cm margin of histologically proven normal mucosa is removed en bloc with the neoplasia. To obtain this, the incision line is conducted along the tatoo spots (Spot Endoscopic Marker, GI Supply, Camp Hill, PA, USA) performed by flexible endoscopy at admission. Mobilization of the residual margins In order to facilitate the suture of the rectal walls and to reduce tension on the suture line, a wide dissection at the deeper level of the oral side of the operative field is recommended. This dissection and undermining follows the avascular plane of the mesorectal fascia (the ‘‘Holy Plane’’ described by Heald). Suture To facilitate its subsequent closure, a PDS 2/0 (EthiconÓ Inc. Somerville, New Jersey, USA) stitch is applied at the center of the defect so as to approximate the oral and caudal margins. The proper suture then starts from the right side of the defect, as seen by the operator, and proceeds from right to left by applying several running 2/0 PDS sutures, each one carrying a silver clip applied by the scrub nurse at its end. The length of each suture is seven centimeters. The needle must be introduced through the full thickness of the rectal wall at a distance of 1 cm from each margin and a running suture is then performed. Given the large size of the defect, the suture on the left side of the screen, as seen by the surgeon, is generally the most difficult part of the operation because the suture is performed in the upper part of the operative field. Filling the defect with glue Before applying the last suture in Group B, the perirectal cavity was filled up with two syringes of a hemostatic glue
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(Floseal, Baxter Healthcare Corporation, Deerfield, Illinois, USA) introduced with a cannula.
Table 2 Results
Filling the rectal ampulla with gauzes At the end of the operation, after removal of the operating rectoscope, the residual rectal ampulla was stuffed with two iodoform gauzes (Luigi Salvadori s.p.a, Florence, Italy) in Group B patients. A transanal Foley catheter is introduced with its tip well above the suture line and its balloon is inflated with 10 cc of water, for postoperative gas evacuation. These are removed after 48 h. Wound dehiscence was defined as minor if it involved less than 50 % and major if this was more than 50 % of the suture line. Patients were then followed up by digital rectal examination, tumor markers’ assay, colonoscopy, pelvic MRI, and total body CT scan every 3 months for the first 3 years and every 6 months for the next 2 years. All data were prospectively collected.
Group A
Group B
p value
Mean age, years (range)
72.1 (47–88)
69.2 (35–87)
0.37
Distance from anal verge, cm (range)
5.9 (1–11)
5.08 (1.5–12)
0.3
Mean lesion diameter, cm (range)
3.7 (1–7)
3.1 (0.5–6)
0.27
Mean operative time, min (range)
161.6 (40–300)
180.2 (90–295)
0.3
Mean specimen volume, cm3 (range)
26.11 (10–40)
28.88 (10–40)
0.59
Mean hospital stay, days (range)
7 (3–13)
8 (5–20)
0.16
Mean follow-up time, months (range)
57.4 (43–89)
26.6 (11–42)
0.0001
Neoadjuvant RadioChemotherapy, n
6
2
0.25
Suture line dehiscence, n (%)
3 (12)
0 (0)
0.23
Table 3 Response to n-RCT
Results Distance from the anal verge and mean diameter of the lesion were 5.9 cm (range 1–11) and 3.7 cm (range 1–7), respectively, in Group A, and 5.08 cm (range 1.5–12) (p = 0.2953) and 3.1 cm (range 0.5–6) (p = 0.2620) in Group B. Mean operative time was 161.6 min (range 40–300) in Group A and 180.2 min (range 90–295) in B (p = 0.2999). Mean specimen volume was 26.11 cm3 (range 10–40) in Group A and 28.88 cm3 in Group B (range 10–40) (p = 0.5839). Mean hospital stay was 7 days (range 3–13) in Group A and 8 days (range 5–20) in Group B (p = 0.1669). Mean follow-up was 57.4 (range 43–89) months in Group A and 26.6 (range 11–42) in Group B (p = 0.0001) (Table 2). Neoadjuvant radio-chemotherapy (n-RCT) was performed in 6 patients in Group A and in 2 patients in Group B (p = 0.25) (Table 3). In twelve iT2 patients n-RCT was not performed because invasive cancer was not proven pre-operatively after endoscopic biopsy. Complete response to n-RCT was observed in 2 out of 6 patients in Group A and in 0 out of 2 patients in Group B. Downstaging was observed in all irradiated patients. Pathological staging (Table 4) was as follows: Group A—low grade dysplasia (1), pTis (4), pT0 (4), pT1 (10), pT2 (4), pT3 (1), carcinoid (1). Group B— moderate dysplasia (1), pTis (7), pT0 (3), pT1 (9), pT2 (3), leiomyoma (1), inflammatory hyperplastic polyp (1). Suture line leakage occurred in 3 patients of Group A (12 %), (1 pT0, 1 pTis, 1 pT1) and in none (0 %) of Group B (p = 0.2347). Fever ([38°C) was observed in 8 patients (32 %) in Group A and in 2 patients (8 %) in Group B
Group A (6 patients)
yT0 (n)
yT1 (n)
yT2 (n)
yT3 (n)
iT2 (n)
1
–
–
–
iT3 (n)
1
1
3
–
Group B (2 patients)
yT0 (n)
yT1 (n)
yT2 (n)
yT3 (n)
iT2 (n)
–
1
–
–
iT3 (n)
–
–
1
–
i imaging, y staging after n-RCT
Table 4 Pathological stage pT stage
Group A: pT(iT)
Group B: pT(iT)
Adenoma
1(4)
1(0)
pTis
4(1)
7(2)
pT0
4(0)
3(2)
pT1
10(9)
9(12)
pT2
4(5)
3(8)
pT3
1(6)
0(1)
Other
1 carcinoide(0)
1 leiomyoma(0) 1 hyperplastic polyp(0)
(p = 0.0738). Mean tumor diameter in the 47 patients without suture line dehiscence was 3.1 cm (range 0.5–7). In group A and B the mean diameter of the tumor in the patients without wound separation was 3.3 cm (range 1–7) and 3.1 cm (range 0.5–6), respectively (p = 0.6670). The mean diameter of the tumor in the three patients with suture line leakage was 6.3 cm (range 6–7). None of these
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patients had undergone n-RCT. Two patients with partial suture line leakage (less than 50 % of the suture line) were treated conservatively with long-term oral antibiotics. One patient experienced a complete wound separation that was treated with a diverting stoma. Patients with suture line leakage underwent rectal endoscopy every 30 days, until wound healing. In the two patients treated conservatively, complete healing occurred after 30 and 45 days, respectively. The patient with the complete wound separation required 3 months to achieve complete healing.
Discussion Anastomotic leakage after anterior resection of the rectum for colorectal cancer is a frequent and dreaded complication. In the literature, the dehiscence rate ranges between 2 and 23 % [7–10]. Several factors influence the anastomosis leakage rate after radical surgery and the issue is still debated [7–15]. Male patients have higher dehiscence rates, as compared to female patients [11–13], due to greater difficulty in performing the anastomosis in a narrow pelvis [12]. Blood loss also seems to be associated with a higher risk of dehiscence due to ischemia [11, 14, 15]. Open or laparoscopic surgery do not influence the anastomotic leakage rate [16, 17], as well as the use of preoperative mechanical bowel preparation [18, 19]. Neoadjuvant radio-chemotherapy seems not to influence the dehiscence rate [20] and, according to Fujita et al. [7], a diverting stoma should be performed only in male patients with low rectal cancer after n-RCT and after steroids therapy. Moreover, ligation of the inferior mesenteric artery at its origin may increase the risk of anastomotic leakage from devascularization of the colonic side of the anastomosis [7, 13]. Other authors reported that anastomotic leakage is more frequent after low rectal resection in patients with tumors located within 7 cm from the anal verge [21, 22]. During TEM, closure of the residual defect is identical in males and females and the presence of a narrow pelvis does not influence the suture line leakage rate. There is no ligation of the mesenteric artery and devascularization does not occur. Nevertheless, the dehiscence rate after traditional full-thickness TEM is not negligible and in the literature, it ranges between 1 and 20.9 % [23–30] (Table 5). Some authors reported personal series in which the defect after tumor excision was not closed, and in these studies a partial or full-thickness excision was performed [31–33]. In the series of Bignell et al. [31], in 65 out of 262 patients the defect was not closed if the excision did not exceed 2 cm. Pelvic sepsis occurred in 2.7 % (7 patients), with five patients managed with a temporary diverting
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Table 5 Full-thickness and ELRR dehiscence rate in literature Authors, year
Technique
Dehiscence/ patients
Dehiscence rate (%)
Ganai 2006 [23]
Full-thickness
2/144
1
De Graaf 2011 [24]
Full-thickness
3/216
1.4
Allaix 2009 [25]
Full-thickness
5/300
1.6
Haag 2008 [26]
Full-thickness
5/288
1.7
Allaix 2012 [27]
Full-thickness
5/293
1.7
Bretagnol 2007 [28]
Full-thickness
4/200
2
Marks 2009 [29] Marks 2003 [30]
Full-thickness Full-thickness
11/62 9/43
17.7 20.9
Lezoche 2005 [2]
ELRR
8/100
8
Lezoche 2012 [3]
ELRR
6/50
12
Present study, Group A
ELRR
3/25
12
Present study, Group B
ELRR
0/25
0
stoma, but the incidence of this complication did not seem to be related to closure of the defect. According to Bignell et al. [31], pelvic sepsis often occurred in patients with tumor located within 2 cm from the dentate line (6.5 vs 0.5 %, p \ 0.02) due to the absence of mesorectum in the distal rectum. Maslekar et al. [33] prefer not to close the defect, particularly in case of wide full-thickness excision, to avoid the risk of rectal stricture. In their series of 52 patients, the authors report one case of post-procedural intraperitoneal perforation, which required a temporary colostomy, and two cases of rectal stricture [33]. No pelvic sepsis was reported [33]. In the Maslekar series, early endoscopic follow-up performed on 7 patients has shown small areas of exuberant tissue proven to be granulation tissue at histology [33]. This is a common finding after TEM and it must not be interpreted as a local recurrence. In the authors’ series, this was found in many patients within one year after surgery. Another interesting finding at endoscopic follow-up in six patients of the present series was the presence of a rectal ‘‘pseudodiverticulum’’ along the previous suture line. In these patients, the tumor was located posteriorly in three patients and laterally in the other three. Moreover, four out of six patients had tumors larger than five centimeters. According to the authors’ experience, this finding is due to the presence of a ‘‘locus minoris resistentiae’’, as a result of the absence of perirectal fat that was removed with the specimen. The authors believe that this finding is not related to suture line leakage but it is due only to the extent of ELRR resection. In fact the layer of mucosal pseudodiverticulum appeared completely regular and no fistula was detected. Other authors have evaluated the incidence of dehiscence in TEM in relation to n-RCT [29]. Marks et al. [29], reported the only study that analyzed wound complications after TEM, in relation to the use or not of n-RCT. In a
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series of 43 patients, a dehiscence rate of 25.6 % (11 patients) after n-RCT was observed [29]. According to Marks et al. [29], this could be due to both sides of the anastomosis having been irradiated. However, in the Marks’ series only 1 out of 11 patients (9 %) needed additional surgery (diverting colostomy) to manage this complication, whereas 91 % of the cases were treated conservatively [29]. The authors’ conclusion based on these data was that n-RCT could be considered a relative factor increasing the suture line leakage rate, but it should not be a contraindication to TEM because the dehiscence rate in irradiated patients and its conservative treatment in most cases make the risk acceptable. In the present study wound separation was not observed in irradiated patients. In twelve iT2 patients who did not undergo n-RCT, only 5 patients were discovered to be pT2 at definitive pathology. Pre-operative imaging in this subgroup of patients overestimated the T-stage in 41 % of them. Two out of three patients with dehiscence had acute cardiac ischemia perioperatively, and peripheral hypoperfusion may have been responsible. It should be emphasized that ELRR is different from full-thickness excision in several aspects, including the fact that it involves more tension on the suture line. Standard full-thickness excision does not include the perirectal fat adjacent to the neoplasia and the residual cavity is smaller than after ELRR. In ELRR, instead, a wider excision of the adjacent perirectal fat leaves a residual cavity of considerable size and the suture line may be subject to tension. For this reason, the plane of the mesorectal fascia is undermined on its oral margin, so as to reduce tension on the suture line. However, ELRR by TEM is associated with 8–12 % dehiscence rate [2, 3] (Table 5). The authors have postulated that there may be other mechanisms responsible for the dehiscence. A wider residual cavity is subject to collection of larger amounts of fluids, which may lead to infection. This infected collection may spontaneously drain through the suture line, which in turn may lead to wound separation. The described technical details have reduced the dehiscence rate in this series from 12 to 0 %, which confirmed the postulated hypothesis. According to the authors, the difference in results is not due to greater surgeon experience and skill in the second group. The authors’ clinical experience with TEM and then with ELRR by TEM started in 1992 and more than 300 patients had undergone TEM or ELRR by TEM for rectal adenoma or carcinoma prior to the beginning of this study. The 50 cases who are the object of the present study were collected well over having completed the learning curve and the authors ascribe the difference in results to the change in surgical technique as described here. The present paper shows the safety and effectiveness of a modified ELRR technique to prevent suture line leakage.
In the literature, no study from other centers about ELRR is available, as shown in Table 5. The weakness of this study, however, is the limited number of patients and the fact that this is a retrospective analysis of prospectively collected data. A larger patients’ series and a randomized trial would be required for more definitive results.
Disclosures Prof. Alessandro M. Paganini, Dr. Andrea Balla, Dr. Silvia Quaresima, Dr. Giancarlo D’Ambrosio, Dr. Paolo Bruzzone, Prof. Emanuele Lezoche, have no conflicts of interest or financial ties to disclose.
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