International Journal of Surgery 15 (2015) 55e60
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Best evidence topic
Is robotic parathyroidectomy a feasible and safe alternative to targeted open parathyroidectomy for the treatment of primary hyperparathyroidism? George Garas a, *, Floyd C. Holsinger b, David G. Grant c, Thanos Athanasiou a, Asit Arora a, Neil Tolley a a b c
Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary's Hospital, London W2 1NY, United Kingdom Department of Otorhinolaryngology and Head & Neck Surgery, Stanford School of Medicine, Stanford, CA, USA Department of Otorhinolaryngology and Head & Neck Surgery, Mayo Clinic, Jacksonville, FL, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 26 May 2014 Received in revised form 16 November 2014 Accepted 24 January 2015 Available online 29 January 2015
A best evidence topic was written according to a structured protocol. The question addressed was whether robotic parathyroidectomy (RP) is a feasible and safe alternative to targeted open parathyroidectomy for the treatment of primary hyperparathyroidism (pHPT). A total of 36 papers were identified using the reported searches of which 5 represented the best evidence to answer the clinical question. The authors, date, journal, study type, population, main outcome measures and results are tabulated. Targeted parathyroidectomy constitutes the co-gold-standard procedure for pHPT with results equivalent to bilateral cervical exploration. This has led to the proliferation of minimally invasive parathyroidectomy (MIP) techniques for pre-operatively localised adenomas. None has been shown to be overwhelmingly superior. RP constitutes the most recent addition. RP overcomes the limitations of conventional endoscopic surgery and simultaneously avoids a neck scar by concealing it in the axilla or infraclavicular area. The evidence from the present review shows that RP is feasible and leads to a superior cosmetic result compared to targeted open parathyroidectomy (TOP) with an equivalent safety profile. As with every surgical technique, appropriate patient selection is crucial. Long-term data are currently awaited on RP especially in view of its high cost and long operative time compared to TOP and other MIP techniques. Hence, RP offers a viable but costly alternative to other forms of MIP in patients where even the smallest and most cosmetic neck scar is not an option. © 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Evidence-based medicine Parathyroid Robotic surgery Follow-up Cosmesis Patient reported outcome measures
1. Introduction A best evidence topic was constructed according to a structured protocol. This is fully described in a previous publication in the International Journal of Surgery [1]. 2. Clinical scenario A 34-year-old Afro-Caribbean woman who has recently suffered several episodes of ureteric colic is found to suffer from primary hyperparathyroidism. On ultrasound she appears to have a 2 cm right inferior parathyroid adenoma. Adenoma location is confirmed
* Corresponding author. E-mail address: [email protected] (G. Garas). http://dx.doi.org/10.1016/j.ijsu.2015.01.019 1743-9191/© 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
with sestamibi scintigraphy and single-photon emission computed tomography. She has no other comorbidities. You advise her that a targeted parathyroidectomy would be the surgical treatment of choice. She is very concerned about the resulting scar in her neck as she has a predisposition to keloid formation. She says she read on the internet about a new robotic approach which would not leave any scar in her neck and enquires about it. You resolve to assess the literature yourself.
3. Three-part question In the treatment of patients with primary hyperparathyroidism is robotic parathyroidectomy a feasible and safe alternative to targeted open parathyroidectomy?
56
G. Garas et al. / International Journal of Surgery 15 (2015) 55e60
4. Search strategy Medline search 1948e2014 using the PubMed interface for the terms: (“robotics”[MeSH Terms] OR “robotics”[All Fields] OR “robotic”[All Fields]) AND (“parathyroidectomy”[MeSH Terms] OR “parathyroidectomy”[All Fields]). In addition, the reference lists of the relevant papers were searched. The search was current as of 15th November 2014. 5. Search outcome Thirty six papers were found using the reported search. Two authors (G.G. and D.G.) independently assessed the titles and abstracts of the identified articles to determine potential relevance. Any disagreement was resolved by discussion or with the opinion of the senior author. After reviewing the abstracts, 34 papers were selected to be fully appraised in view of relevance and methods used. From these, 4 were irrelevant, 6 were review articles, 3 were in a language other than English, 15 referred to robotic thoracoscopic resection of ectopic mediastinal parathyroid adenomas and one was a case report. Inclusion criteria included studies of any size, prospective or retrospective in design assessing robotic parathyroidectomy either in isolation or in comparison to targeted open parathyroidectomy. Included studies must have been composed of adults who had pre-operative localisation of their parathyroid adenoma. Exclusion criteria included studies evaluating robotic thoracoscopic parathyroidectomy for ectopic mediastinal parathyroid adenomas. However, due to the paucity of studies limited to patients having only cervical parathyroid adenomas, studies with a mixed cohort which included patients undergoing robotic thoracoscopic parathyroidectomy or robotic transaxillary thyroidectomy were reviewed, but only outcomes referring to those patients undergoing robotic surgery for cervical parathyroid adenomas used in the data analysis and evidence synthesis. Review articles and articles not published in the English language were also excluded. Based on design, number of patients and origin (high volume/ specialised centres) 5 papers were chosen as representing the best evidence to answer the clinical question. 6. Results The results of the five papers (two prospective cohort studies, two retrospective cohort studies and one case control study) are summarised in Table 1. 7. Discussion Parathyroid surgery has evolved since its first successful description by Felix Mandl in 1925 [2]. Presently, targeted parathyroidectomy constitutes the co-gold-standard procedure for primary hyperparathyroidism (pHPT) with results equivalent to bilateral cervical exploration. This has led to the proliferation of minimal access techniques for the treatment of pHPT where the adenoma has been localized pre-operatively [3]. Despite the numerous techniques described in the literature none has been shown to be overwhelmingly superior [2]. The latest addition to the armamentarium of endocrine surgeons is robotic parathyroidectomy (RP). This technique uses robotic technology to address the limitations of conventional endoscopic surgery. In addition to being less technically challenging than the extra-cervical endoscopic approach it also avoids a neck scar by concealing it in the axilla or infraclavicular area. To date, there is no randomised control trial (RCT) to assess how this innovative technique compares to targeted open parathyroidectomy (TOP). However, there are a handful of non-
randomised studies that evaluate RP [3e6], with one comparing it against TOP [7]. In the first study to describe RP in the literature, Tolley et al. [3] prospectively evaluated 11 patients with pHPT, all of whom had their parathyroid adenoma preoperatively localised. Patients with a history of significant thyroiditis, bulky thyroid disease, previous neck surgery, or a suspicion of malignancy were excluded. The approach used involved an ipsilateral infraclavicular incision along with 3 small incisions in the ipsilateral anterior axillary line. If body habitus permitted, the inferior trocar was inserted through an ipsilateral periareolar incision. The parathyroid adenoma was successfully excised in all 11 patients and there were no complications. Blood loss was negligible (30 kg m2), history of prior neck surgery Intraoperative PTH measurement was used routinely, authors do not comment on the use of IONM Retrospective study of 9 patients that underwent RP: 6 patients underwent RP for a parathyroid adenoma, 2 underwent RT for an intrathyroid parathyroid adenoma and 1 underwent RP and RT for an atypical parathyroid adenoma (mean age: 37.5 ± 8.1 years, 8 females and 1 male) Inclusion criteria: patients with pHPT and localising studies indicating single gland disease Exclusion criteria: failure of preoperative localisation of parathyroid adenoma Both IONM and intraoperative PTH measurement were used routinely
Level III retrospective cohort study
Biochemical cure (normalisation of calcium and PTH) Operative time Length of hospital stay Presence of complications Postoperative pain (VAS) Postoperative voice (subjective evaluation)
All 8 RP patients were cured of their pHPT No need for conversion to open surgery Total operation time for RP was 184 ± 58 min All patients were discharged on postoperative day 1 Mean pain scores were 6.0 ± 2.0 on postoperative day 1 and this dropped to 1.0 ± 2.1 on postoperative day 14 There was one complication: a postoperative seroma that was managed conservatively in the outpatient setting No subjective voice problems in any patient
RP is feasible and safe provided patients are carefully selected An obvious setback for RP is its long duration (184 ± 58 min) Only one minor complication (seroma treated conservatively in the outpatient setting) Strengths: long follow-up period (median: 29 months with range: 6e38 months), use of VAS to formally evaluate postoperative pain Limitations: retrospective study, small number of RP cases (n ¼ 8), no use of fibreoptic laryngoscopy to formally assess RLN function, no evaluation of learning curve or cosmetic satisfaction
Level III retrospective cohort study
Biochemical cure (normalisation of calcium and PTH) Histopathological confirmation of hypercellular parathyroid tissue in the excised lesion Operative time Presence of complications Length of hospital stay Need for conversion to open surgery Subjective evaluation of cosmesis
RP is feasible and safe in appropriately selected patients with pHPT An obvious setback for RP is its long duration (119 ± 15.6 min) No complications seen with RP in this cohort Subjective cosmetic results were considered excellent due to hidden scar in the neutral position Strengths: relatively long follow-up period (6 months), RLN function formally assessed by fibreoptic laryngoscopy performed pre- and postoperatively in all patients Limitations: retrospective study, small number of RP cases (n ¼ 9), absence of control group for comparison, no evaluation of PROMs, no evaluation of learning curve
Level IIIa case control study
Biochemical cure (normalisation of calcium and PTH) Operative time Presence of complications Need for conversion to open surgery Comparison of RP to TOP
Curative resection was established in all 9 patients One patient required conversion to cervicotomy and 4gland exploration prior to being cured as IOPTH suggested the presence of multiglandular disease Total operation time for RP was 119 ± 15.6 min Total blood loss for RP was 21 ± 19.9 ml Final pathologic evaluation was consistent with parathyroid adenoma for all patients (conversion patient had a double adenoma not identified by preoperative imaging) There were no complications All patients discharged within 23-h of surgery Long-term (6 months) cure achieved in all patients Subjective cosmetic results were considered excellent All RP patients became eucalcaemic postoperatively Total operation time for RP vs. TOP was 186 ± 84.2 min vs. 86 ± 27.9 min (p ¼ 0.001) A learning curve was demonstrated for RP In the RP arm 1 patient
Noureldine et al., 2014 [6], USA
Foley et al., 2012 [7], USA
Mixed cohort of 43 patients: 11 RAT, 4 RP, 16 OT (RAT control) and 12 TOP (RP control) Hence: 4 RP (2 focal, 2 unilateral, mean age: 53 ± 13.8 years, 3 female and 1 male) vs. 12 matched controls (TOP) for age, BMI, gender and parathyroid adenoma size (mean age:
RP is feasible and safe in appropriately selected patients with pHPT This is the only study in the literature to directly compare RP with its open equivalent Authors initially used an additional trocar through the anterior chest wall but with experience confined (continued on next page)
58
G. Garas et al. / International Journal of Surgery 15 (2015) 55e60
Table 1 (continued ) Author, date and country
Patient group
Study type and level of evidence
Outcomes
53 ± 11.2 years, 9 female and 3 male) Inclusion criteria (for RP arm): favourable body habitus (BMI 35 kg m2 or large body frame), suspicion of carcinoma Both IONM and intraoperative PTH measurement were used routinely
Level IIb prospective cohort study
For RP arm: Biochemical cure (normalisation of calcium and PTH) Histopathological confirmation of hypercellular parathyroid tissue in the excised lesion Operative time Presence of complications Need for conversion to open surgery
The parathyroid adenoma was successfully excised in both cases Final pathologic evaluation was consistent with a parathyroid adenoma for both patients There were no complications Total operative times was 115 and 102 min respectively
Tolley et al., 2011 [3], UK
Prospective study of 11 patients that underwent RP (mean age: 58.4 ± 11.7 years, 8 females and 3 males) Inclusion criteria: biochemical diagnosis of pHPT, triple-modality concordant localization with US, sestamibi and SPECT-CT Exclusion criteria: history
Level IIb prospective cohort study
Biochemical cure (normalisation of calcium and PTH) Histopathological confirmation of hypercellular parathyroid tissue in the excised lesion Operative time Blood loss Presence of complications
The parathyroid adenoma was successfully excised in all cases with negligible blood loss (
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Best evidence topic
Is robotic parathyroidectomy a feasible and safe alternative to targeted open parathyroidectomy for the treatment of primary hyperparathyroidism? George Garas a, *, Floyd C. Holsinger b, David G. Grant c, Thanos Athanasiou a, Asit Arora a, Neil Tolley a a b c
Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary's Hospital, London W2 1NY, United Kingdom Department of Otorhinolaryngology and Head & Neck Surgery, Stanford School of Medicine, Stanford, CA, USA Department of Otorhinolaryngology and Head & Neck Surgery, Mayo Clinic, Jacksonville, FL, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 26 May 2014 Received in revised form 16 November 2014 Accepted 24 January 2015 Available online 29 January 2015
A best evidence topic was written according to a structured protocol. The question addressed was whether robotic parathyroidectomy (RP) is a feasible and safe alternative to targeted open parathyroidectomy for the treatment of primary hyperparathyroidism (pHPT). A total of 36 papers were identified using the reported searches of which 5 represented the best evidence to answer the clinical question. The authors, date, journal, study type, population, main outcome measures and results are tabulated. Targeted parathyroidectomy constitutes the co-gold-standard procedure for pHPT with results equivalent to bilateral cervical exploration. This has led to the proliferation of minimally invasive parathyroidectomy (MIP) techniques for pre-operatively localised adenomas. None has been shown to be overwhelmingly superior. RP constitutes the most recent addition. RP overcomes the limitations of conventional endoscopic surgery and simultaneously avoids a neck scar by concealing it in the axilla or infraclavicular area. The evidence from the present review shows that RP is feasible and leads to a superior cosmetic result compared to targeted open parathyroidectomy (TOP) with an equivalent safety profile. As with every surgical technique, appropriate patient selection is crucial. Long-term data are currently awaited on RP especially in view of its high cost and long operative time compared to TOP and other MIP techniques. Hence, RP offers a viable but costly alternative to other forms of MIP in patients where even the smallest and most cosmetic neck scar is not an option. © 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Evidence-based medicine Parathyroid Robotic surgery Follow-up Cosmesis Patient reported outcome measures
1. Introduction A best evidence topic was constructed according to a structured protocol. This is fully described in a previous publication in the International Journal of Surgery [1]. 2. Clinical scenario A 34-year-old Afro-Caribbean woman who has recently suffered several episodes of ureteric colic is found to suffer from primary hyperparathyroidism. On ultrasound she appears to have a 2 cm right inferior parathyroid adenoma. Adenoma location is confirmed
* Corresponding author. E-mail address: [email protected] (G. Garas). http://dx.doi.org/10.1016/j.ijsu.2015.01.019 1743-9191/© 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
with sestamibi scintigraphy and single-photon emission computed tomography. She has no other comorbidities. You advise her that a targeted parathyroidectomy would be the surgical treatment of choice. She is very concerned about the resulting scar in her neck as she has a predisposition to keloid formation. She says she read on the internet about a new robotic approach which would not leave any scar in her neck and enquires about it. You resolve to assess the literature yourself.
3. Three-part question In the treatment of patients with primary hyperparathyroidism is robotic parathyroidectomy a feasible and safe alternative to targeted open parathyroidectomy?
56
G. Garas et al. / International Journal of Surgery 15 (2015) 55e60
4. Search strategy Medline search 1948e2014 using the PubMed interface for the terms: (“robotics”[MeSH Terms] OR “robotics”[All Fields] OR “robotic”[All Fields]) AND (“parathyroidectomy”[MeSH Terms] OR “parathyroidectomy”[All Fields]). In addition, the reference lists of the relevant papers were searched. The search was current as of 15th November 2014. 5. Search outcome Thirty six papers were found using the reported search. Two authors (G.G. and D.G.) independently assessed the titles and abstracts of the identified articles to determine potential relevance. Any disagreement was resolved by discussion or with the opinion of the senior author. After reviewing the abstracts, 34 papers were selected to be fully appraised in view of relevance and methods used. From these, 4 were irrelevant, 6 were review articles, 3 were in a language other than English, 15 referred to robotic thoracoscopic resection of ectopic mediastinal parathyroid adenomas and one was a case report. Inclusion criteria included studies of any size, prospective or retrospective in design assessing robotic parathyroidectomy either in isolation or in comparison to targeted open parathyroidectomy. Included studies must have been composed of adults who had pre-operative localisation of their parathyroid adenoma. Exclusion criteria included studies evaluating robotic thoracoscopic parathyroidectomy for ectopic mediastinal parathyroid adenomas. However, due to the paucity of studies limited to patients having only cervical parathyroid adenomas, studies with a mixed cohort which included patients undergoing robotic thoracoscopic parathyroidectomy or robotic transaxillary thyroidectomy were reviewed, but only outcomes referring to those patients undergoing robotic surgery for cervical parathyroid adenomas used in the data analysis and evidence synthesis. Review articles and articles not published in the English language were also excluded. Based on design, number of patients and origin (high volume/ specialised centres) 5 papers were chosen as representing the best evidence to answer the clinical question. 6. Results The results of the five papers (two prospective cohort studies, two retrospective cohort studies and one case control study) are summarised in Table 1. 7. Discussion Parathyroid surgery has evolved since its first successful description by Felix Mandl in 1925 [2]. Presently, targeted parathyroidectomy constitutes the co-gold-standard procedure for primary hyperparathyroidism (pHPT) with results equivalent to bilateral cervical exploration. This has led to the proliferation of minimal access techniques for the treatment of pHPT where the adenoma has been localized pre-operatively [3]. Despite the numerous techniques described in the literature none has been shown to be overwhelmingly superior [2]. The latest addition to the armamentarium of endocrine surgeons is robotic parathyroidectomy (RP). This technique uses robotic technology to address the limitations of conventional endoscopic surgery. In addition to being less technically challenging than the extra-cervical endoscopic approach it also avoids a neck scar by concealing it in the axilla or infraclavicular area. To date, there is no randomised control trial (RCT) to assess how this innovative technique compares to targeted open parathyroidectomy (TOP). However, there are a handful of non-
randomised studies that evaluate RP [3e6], with one comparing it against TOP [7]. In the first study to describe RP in the literature, Tolley et al. [3] prospectively evaluated 11 patients with pHPT, all of whom had their parathyroid adenoma preoperatively localised. Patients with a history of significant thyroiditis, bulky thyroid disease, previous neck surgery, or a suspicion of malignancy were excluded. The approach used involved an ipsilateral infraclavicular incision along with 3 small incisions in the ipsilateral anterior axillary line. If body habitus permitted, the inferior trocar was inserted through an ipsilateral periareolar incision. The parathyroid adenoma was successfully excised in all 11 patients and there were no complications. Blood loss was negligible (30 kg m2), history of prior neck surgery Intraoperative PTH measurement was used routinely, authors do not comment on the use of IONM Retrospective study of 9 patients that underwent RP: 6 patients underwent RP for a parathyroid adenoma, 2 underwent RT for an intrathyroid parathyroid adenoma and 1 underwent RP and RT for an atypical parathyroid adenoma (mean age: 37.5 ± 8.1 years, 8 females and 1 male) Inclusion criteria: patients with pHPT and localising studies indicating single gland disease Exclusion criteria: failure of preoperative localisation of parathyroid adenoma Both IONM and intraoperative PTH measurement were used routinely
Level III retrospective cohort study
Biochemical cure (normalisation of calcium and PTH) Operative time Length of hospital stay Presence of complications Postoperative pain (VAS) Postoperative voice (subjective evaluation)
All 8 RP patients were cured of their pHPT No need for conversion to open surgery Total operation time for RP was 184 ± 58 min All patients were discharged on postoperative day 1 Mean pain scores were 6.0 ± 2.0 on postoperative day 1 and this dropped to 1.0 ± 2.1 on postoperative day 14 There was one complication: a postoperative seroma that was managed conservatively in the outpatient setting No subjective voice problems in any patient
RP is feasible and safe provided patients are carefully selected An obvious setback for RP is its long duration (184 ± 58 min) Only one minor complication (seroma treated conservatively in the outpatient setting) Strengths: long follow-up period (median: 29 months with range: 6e38 months), use of VAS to formally evaluate postoperative pain Limitations: retrospective study, small number of RP cases (n ¼ 8), no use of fibreoptic laryngoscopy to formally assess RLN function, no evaluation of learning curve or cosmetic satisfaction
Level III retrospective cohort study
Biochemical cure (normalisation of calcium and PTH) Histopathological confirmation of hypercellular parathyroid tissue in the excised lesion Operative time Presence of complications Length of hospital stay Need for conversion to open surgery Subjective evaluation of cosmesis
RP is feasible and safe in appropriately selected patients with pHPT An obvious setback for RP is its long duration (119 ± 15.6 min) No complications seen with RP in this cohort Subjective cosmetic results were considered excellent due to hidden scar in the neutral position Strengths: relatively long follow-up period (6 months), RLN function formally assessed by fibreoptic laryngoscopy performed pre- and postoperatively in all patients Limitations: retrospective study, small number of RP cases (n ¼ 9), absence of control group for comparison, no evaluation of PROMs, no evaluation of learning curve
Level IIIa case control study
Biochemical cure (normalisation of calcium and PTH) Operative time Presence of complications Need for conversion to open surgery Comparison of RP to TOP
Curative resection was established in all 9 patients One patient required conversion to cervicotomy and 4gland exploration prior to being cured as IOPTH suggested the presence of multiglandular disease Total operation time for RP was 119 ± 15.6 min Total blood loss for RP was 21 ± 19.9 ml Final pathologic evaluation was consistent with parathyroid adenoma for all patients (conversion patient had a double adenoma not identified by preoperative imaging) There were no complications All patients discharged within 23-h of surgery Long-term (6 months) cure achieved in all patients Subjective cosmetic results were considered excellent All RP patients became eucalcaemic postoperatively Total operation time for RP vs. TOP was 186 ± 84.2 min vs. 86 ± 27.9 min (p ¼ 0.001) A learning curve was demonstrated for RP In the RP arm 1 patient
Noureldine et al., 2014 [6], USA
Foley et al., 2012 [7], USA
Mixed cohort of 43 patients: 11 RAT, 4 RP, 16 OT (RAT control) and 12 TOP (RP control) Hence: 4 RP (2 focal, 2 unilateral, mean age: 53 ± 13.8 years, 3 female and 1 male) vs. 12 matched controls (TOP) for age, BMI, gender and parathyroid adenoma size (mean age:
RP is feasible and safe in appropriately selected patients with pHPT This is the only study in the literature to directly compare RP with its open equivalent Authors initially used an additional trocar through the anterior chest wall but with experience confined (continued on next page)
58
G. Garas et al. / International Journal of Surgery 15 (2015) 55e60
Table 1 (continued ) Author, date and country
Patient group
Study type and level of evidence
Outcomes
53 ± 11.2 years, 9 female and 3 male) Inclusion criteria (for RP arm): favourable body habitus (BMI 35 kg m2 or large body frame), suspicion of carcinoma Both IONM and intraoperative PTH measurement were used routinely
Level IIb prospective cohort study
For RP arm: Biochemical cure (normalisation of calcium and PTH) Histopathological confirmation of hypercellular parathyroid tissue in the excised lesion Operative time Presence of complications Need for conversion to open surgery
The parathyroid adenoma was successfully excised in both cases Final pathologic evaluation was consistent with a parathyroid adenoma for both patients There were no complications Total operative times was 115 and 102 min respectively
Tolley et al., 2011 [3], UK
Prospective study of 11 patients that underwent RP (mean age: 58.4 ± 11.7 years, 8 females and 3 males) Inclusion criteria: biochemical diagnosis of pHPT, triple-modality concordant localization with US, sestamibi and SPECT-CT Exclusion criteria: history
Level IIb prospective cohort study
Biochemical cure (normalisation of calcium and PTH) Histopathological confirmation of hypercellular parathyroid tissue in the excised lesion Operative time Blood loss Presence of complications
The parathyroid adenoma was successfully excised in all cases with negligible blood loss (
