EUROPEAN UROLOGY 68 (2015) 302–310
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Surgery in Motion
Transvaginal Natural Orifice Transluminal Endoscopic Nephrectomy in a Series of 63 Cases: Stepwise Transition From Hybrid to Pure NOTES Yijun Xue a,y, Xiaofeng Zou a,y,*, Guoxi Zhang a,y, Yuanhu Yuan a,y, Rihai Xiao a, Yunfeng Liao a, Xin Zhong a, Bo Jiang a, Ruiquan Xu a, Yuhua Zou a, Gang Xu a, Kunlin Xie a, Xu Zhang b a
Department of Urology, First Affiliated Hospital of Gannan Medical University, Ganzhou, People’s Republic of China;
b
Department of Urology, Clinical
Division of Surgery, Chinese PLA General Hospital, Beijing, People’s Republic of China
Article info
Abstract
Article history: Accepted March 14, 2015
Background: The feasibility of hybrid transvaginal NOTES (natural orifice transluminal endoscopic
Keywords: Minimally invasive surgery Natural orifice transluminal endoscopic surgery NOTES Nephrectomy Transvaginal surgery Please visit www.europeanurology.com and www.urosource.com to view the accompanying video.
surgery) nephrectomy (HTNN) has already been demonstrated. However, pure transvaginal NOTES nephrectomy (PTNN) has been limited to animal experiments with only one report of its use in humans. Objective: To describe our initial experience with HTNN and a stepwise transition towards PTNN. Design, setting, and participants: Between May 2010 and September 2011, 63 patients underwent nephrectomy (60 HTNNs and 3 PTNNs) in our institution, including 45 patients with benign renal disease and 18 patients with malignant renal disease. Surgical procedure: Of the HTNNs, 33 were performed using two umbilical trocars and one transvaginal trocar, and 27 were performed using one umbilical trocar and a transvaginal multiinstrument access port; 3 PTNNs were performed using a self-developed, three-channel ZOU-port without any transumbilical assistance. Outcome measurements and statistical analysis: All data referring to patient demographics, surgery, pathology, and perioperative outcomes were recorded. Sexual function was assessed with the Female Sexual Function Index (FSFI) questionnaire before and after surgery. The cosmetic result was investigated by administering the Patient Scar Assessment Questionnaire and Scoring System (PSAQ). Results and limitations: A total of 59 HTNNs and 3 PTNNs were successfully performed. One patient was converted to open surgery because of injury to the inferior vena cava. The mean operative time was 130 min (range: 100–260 min) for HTNN and 193 min (range: 180–210 min) for PTNN. The mean estimated blood loss was 150 ml. The mean postoperative hospital stay was 7.4 d. Forty-eight patients completed the FSFI questionnaire, and analysis did not show differences in FSFI scores before and after surgery. The better cosmetic results were confirmed by the PSAQ score. Conclusions: HTNN is feasible and safe in appropriate patients. Existing instruments are adequate for HTNN, but significant improvement is still needed. PTNN is technically challenging, but is feasible and may be performed safely. Further improvement of instruments is necessary for PTNN. Clinical investigation in comparison to the established techniques should take place to evaluate the outcome of technique. Patient summary: Pure transvaginal natural orifice transluminal endoscopic nephrectomy (PTNN) is technically challenging but feasible and may be performed safely. Further improvements in instruments are necessary for PTNN.
# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
y These authors contributed equally to this work. * Corresponding author. Department of Urology, First Affiliated Hospital of Gannan Medical University, No. 23, Qing Nian Road, Ganzhou 341000, People’s Republic of China. Tel. +86 797 8269588; Fax: +86 797 8269500. E-mail address: [email protected] (X. Zou).
http://dx.doi.org/10.1016/j.eururo.2015.03.033 0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 68 (2015) 302–310
1.
303
The study was approved by the ethics committee of Gannan Medical
Introduction
University. All patients were adequately informed of the possible risks
Laparoscopy is a well-established alternative to open surgery, with benefits in terms of decreased hospital stay, postoperative pain, surgical site infections, improved cosmesis, and early return to daily occupation [1,2]. To further reduce the morbidity and scarring associated with laparoscopic surgery, a recent innovation—natural orifice translumenal endoscopic surgery (NOTES)—was developed. NOTES is a surgical modality that uses empty organs (eg, vagina, gastrointestinal tract) to access the peritoneal cavity, avoiding (pure NOTES) or minimising (hybrid or assisted NOTES) skin incisions [3]. In urology, the concept of NOTES was initiated with the use of natural orifices to extract surgical specimens. In 1993, vaginal extraction of an intact kidney following laparoscopic nephrectomy was first reported by Breda et al [4]; a larger series was reported by Gill et al in 2002 [5]. Thus far, NOTES has been successfully completed experimentally via transgastric [6], transvaginal [7], transrectal [8,9], and transvesical [10] routes. In the field of human urology, transvaginal access is the most common. The transition of NOTES to clinical practice in human urology has been ideal—a slow but definitive evolution. In 2008, Branco et al [11] reported the first hybrid transvaginal NOTES nephrectomy (HTNN). Following this initial report, several other early experiences were published and gave favourable results, including simple, radical, and living donor nephrectomy [12–17]. In 2010, Kaouk et al [18] reported the first clinical pure transvaginal NOTES nephrectomy (PTNN). However, many of the instruments’ limitations and technical challenges have precluded the widespread adoption of this technique. With this background, we report our stepwise transition from HTNN to three successful clinical cases of PTNN in a series of 63 human patients that demonstrates our explorative history with pure NOTES. We will highlight our institutional experience with the evolution of the procedure.
2.
Patients and methods
2.1.
Patients
and benefits of this new approach and signed a written consent agreeing to undergo the described procedure and to allow the use of their data prospectively. All procedures were performed by a surgeon (X. Zou) with advanced laparoscopic skills. The exclusion criteria were as follows: pelvic inflammatory disease, vaginal narrowing, body mass index >30 kg/m2, unmarried status, preparation for pregnancy, and previous major abdominal surgery.
2.2.
Preoperative preparation
Vaginal irrigation with iodophors was performed, and oral antibiotics including metronidazole and norfloxacin were given for 3 d before surgery. Each patient underwent a mechanical bowel preparation with the use of enema the morning of surgery and had a clear liquid diet 1 d prior to surgery.
2.3.
Surgical technique
Under general anaesthesia, a nasogastric tube and transurethral catheter were placed to decompress the stomach and bladder. The patients were placed in lithotomy position with the affected side elevated at 308. In our initial 33 cases, 5- and 10-mm trocars were placed at the right and left medial margins of the umbilicus. A lengthened 10-mm trocar was placed through the posterior vaginal fornix into the abdominal cavity under direct vision using a 10-mm 308 or a flexible-tip 5.4-mm 08 laparoscope (Olympus Optical, Tokyo, Japan). Dissection was performed transumbilically using standard laparoscopic instruments and a 5-mm harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH, USA) (Fig. 1). This procedure was roughly analogous to that described by Alcaraz et al [14]. In the subsequent 25 procedures, only a 10-mm umbilical trocar was introduced into abdominal cavity and a flexible-tip 5.4-mm laparoscope
[(Fig._1)TD$IG]
was used. A multi-instrument access port (TriPort; Olympus Medical
From May 2010 to September 2011, 63 patients underwent transvaginal NOTES nephrectomy in our institution. All cases were evaluated preoperatively with ultrasonography, nephrogram, intravenous urogram, and computed tomography. Patients with tumours who were included in the study were not candidates for partial nephrectomy (eg, localisation in hilum, significant involvement of pelvicalyceal system) or the patient decided to undergo a radical procedure to reach oncologic safety despite the selective indications for partial nephrectomy. In the latter case, the patient decided between a partial or radical nephrectomy after a comprehensive discussion. If the patient decided to undergo the radical procedure and respected the indicated criteria, the possibility of transvaginal NOTES radical nephrectomy was proposed. In cases of simple nephrectomy, a diuretic renogram confirmed
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Surgery in Motion
Transvaginal Natural Orifice Transluminal Endoscopic Nephrectomy in a Series of 63 Cases: Stepwise Transition From Hybrid to Pure NOTES Yijun Xue a,y, Xiaofeng Zou a,y,*, Guoxi Zhang a,y, Yuanhu Yuan a,y, Rihai Xiao a, Yunfeng Liao a, Xin Zhong a, Bo Jiang a, Ruiquan Xu a, Yuhua Zou a, Gang Xu a, Kunlin Xie a, Xu Zhang b a
Department of Urology, First Affiliated Hospital of Gannan Medical University, Ganzhou, People’s Republic of China;
b
Department of Urology, Clinical
Division of Surgery, Chinese PLA General Hospital, Beijing, People’s Republic of China
Article info
Abstract
Article history: Accepted March 14, 2015
Background: The feasibility of hybrid transvaginal NOTES (natural orifice transluminal endoscopic
Keywords: Minimally invasive surgery Natural orifice transluminal endoscopic surgery NOTES Nephrectomy Transvaginal surgery Please visit www.europeanurology.com and www.urosource.com to view the accompanying video.
surgery) nephrectomy (HTNN) has already been demonstrated. However, pure transvaginal NOTES nephrectomy (PTNN) has been limited to animal experiments with only one report of its use in humans. Objective: To describe our initial experience with HTNN and a stepwise transition towards PTNN. Design, setting, and participants: Between May 2010 and September 2011, 63 patients underwent nephrectomy (60 HTNNs and 3 PTNNs) in our institution, including 45 patients with benign renal disease and 18 patients with malignant renal disease. Surgical procedure: Of the HTNNs, 33 were performed using two umbilical trocars and one transvaginal trocar, and 27 were performed using one umbilical trocar and a transvaginal multiinstrument access port; 3 PTNNs were performed using a self-developed, three-channel ZOU-port without any transumbilical assistance. Outcome measurements and statistical analysis: All data referring to patient demographics, surgery, pathology, and perioperative outcomes were recorded. Sexual function was assessed with the Female Sexual Function Index (FSFI) questionnaire before and after surgery. The cosmetic result was investigated by administering the Patient Scar Assessment Questionnaire and Scoring System (PSAQ). Results and limitations: A total of 59 HTNNs and 3 PTNNs were successfully performed. One patient was converted to open surgery because of injury to the inferior vena cava. The mean operative time was 130 min (range: 100–260 min) for HTNN and 193 min (range: 180–210 min) for PTNN. The mean estimated blood loss was 150 ml. The mean postoperative hospital stay was 7.4 d. Forty-eight patients completed the FSFI questionnaire, and analysis did not show differences in FSFI scores before and after surgery. The better cosmetic results were confirmed by the PSAQ score. Conclusions: HTNN is feasible and safe in appropriate patients. Existing instruments are adequate for HTNN, but significant improvement is still needed. PTNN is technically challenging, but is feasible and may be performed safely. Further improvement of instruments is necessary for PTNN. Clinical investigation in comparison to the established techniques should take place to evaluate the outcome of technique. Patient summary: Pure transvaginal natural orifice transluminal endoscopic nephrectomy (PTNN) is technically challenging but feasible and may be performed safely. Further improvements in instruments are necessary for PTNN.
# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
y These authors contributed equally to this work. * Corresponding author. Department of Urology, First Affiliated Hospital of Gannan Medical University, No. 23, Qing Nian Road, Ganzhou 341000, People’s Republic of China. Tel. +86 797 8269588; Fax: +86 797 8269500. E-mail address: [email protected] (X. Zou).
http://dx.doi.org/10.1016/j.eururo.2015.03.033 0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 68 (2015) 302–310
1.
303
The study was approved by the ethics committee of Gannan Medical
Introduction
University. All patients were adequately informed of the possible risks
Laparoscopy is a well-established alternative to open surgery, with benefits in terms of decreased hospital stay, postoperative pain, surgical site infections, improved cosmesis, and early return to daily occupation [1,2]. To further reduce the morbidity and scarring associated with laparoscopic surgery, a recent innovation—natural orifice translumenal endoscopic surgery (NOTES)—was developed. NOTES is a surgical modality that uses empty organs (eg, vagina, gastrointestinal tract) to access the peritoneal cavity, avoiding (pure NOTES) or minimising (hybrid or assisted NOTES) skin incisions [3]. In urology, the concept of NOTES was initiated with the use of natural orifices to extract surgical specimens. In 1993, vaginal extraction of an intact kidney following laparoscopic nephrectomy was first reported by Breda et al [4]; a larger series was reported by Gill et al in 2002 [5]. Thus far, NOTES has been successfully completed experimentally via transgastric [6], transvaginal [7], transrectal [8,9], and transvesical [10] routes. In the field of human urology, transvaginal access is the most common. The transition of NOTES to clinical practice in human urology has been ideal—a slow but definitive evolution. In 2008, Branco et al [11] reported the first hybrid transvaginal NOTES nephrectomy (HTNN). Following this initial report, several other early experiences were published and gave favourable results, including simple, radical, and living donor nephrectomy [12–17]. In 2010, Kaouk et al [18] reported the first clinical pure transvaginal NOTES nephrectomy (PTNN). However, many of the instruments’ limitations and technical challenges have precluded the widespread adoption of this technique. With this background, we report our stepwise transition from HTNN to three successful clinical cases of PTNN in a series of 63 human patients that demonstrates our explorative history with pure NOTES. We will highlight our institutional experience with the evolution of the procedure.
2.
Patients and methods
2.1.
Patients
and benefits of this new approach and signed a written consent agreeing to undergo the described procedure and to allow the use of their data prospectively. All procedures were performed by a surgeon (X. Zou) with advanced laparoscopic skills. The exclusion criteria were as follows: pelvic inflammatory disease, vaginal narrowing, body mass index >30 kg/m2, unmarried status, preparation for pregnancy, and previous major abdominal surgery.
2.2.
Preoperative preparation
Vaginal irrigation with iodophors was performed, and oral antibiotics including metronidazole and norfloxacin were given for 3 d before surgery. Each patient underwent a mechanical bowel preparation with the use of enema the morning of surgery and had a clear liquid diet 1 d prior to surgery.
2.3.
Surgical technique
Under general anaesthesia, a nasogastric tube and transurethral catheter were placed to decompress the stomach and bladder. The patients were placed in lithotomy position with the affected side elevated at 308. In our initial 33 cases, 5- and 10-mm trocars were placed at the right and left medial margins of the umbilicus. A lengthened 10-mm trocar was placed through the posterior vaginal fornix into the abdominal cavity under direct vision using a 10-mm 308 or a flexible-tip 5.4-mm 08 laparoscope (Olympus Optical, Tokyo, Japan). Dissection was performed transumbilically using standard laparoscopic instruments and a 5-mm harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH, USA) (Fig. 1). This procedure was roughly analogous to that described by Alcaraz et al [14]. In the subsequent 25 procedures, only a 10-mm umbilical trocar was introduced into abdominal cavity and a flexible-tip 5.4-mm laparoscope
[(Fig._1)TD$IG]
was used. A multi-instrument access port (TriPort; Olympus Medical
From May 2010 to September 2011, 63 patients underwent transvaginal NOTES nephrectomy in our institution. All cases were evaluated preoperatively with ultrasonography, nephrogram, intravenous urogram, and computed tomography. Patients with tumours who were included in the study were not candidates for partial nephrectomy (eg, localisation in hilum, significant involvement of pelvicalyceal system) or the patient decided to undergo a radical procedure to reach oncologic safety despite the selective indications for partial nephrectomy. In the latter case, the patient decided between a partial or radical nephrectomy after a comprehensive discussion. If the patient decided to undergo the radical procedure and respected the indicated criteria, the possibility of transvaginal NOTES radical nephrectomy was proposed. In cases of simple nephrectomy, a diuretic renogram confirmed
