LETTER TO THE EDITOR Laparoscopic “Successful” Excision of Deep Endometriosis: A Fertility-enhancing Surgery To the Editor: e congratulate the authors for these prospective clinical outcome data after radical surgery with or without bowel resection for deep endometriotic (DE) nodules.1 However, instead of participating in technical debate on bowel resection, findings on pregnancy rate merit attention, as they influence strategies to counsel patients suffering from this enigmatic pathology. Surgical treatment of colorectal DE nodules is difficult and challenging. Laparoscopic segmental excision of the rectum and other types of colorectal surgery such as discoid excision and shaving for DE nodule removal have become increasingly popular, although the most appropriate surgical approach remains controversial.2,3 Surgical series often deal with a wide range of clinical and anatomical variables of colon-rectal DE nodules, and simple questions such as the importance of size, localization, and depth of infiltration remain often unanswered.3 All these issues, coupled with the demanding complexity of surgery, the variable skill of surgeons, and the absence of a codified training dramatically, affect the quality of publications and their translation into clinical practice. In these regards, the present study provides some interesting considerations. Major concerns of DE nodules are represented by fertility and pelvic pain along with their interrelationship. Improvement of fertility is often an underestimated objective for women undergoing surgery for endometriosis. We strongly agree with the authors that most patients have a combined problem of pain and unfulfilled or uncompleted child wish. Furthermore, it is important to realize that many women with DE nodules have been told for many years that they would never become pregnant as a result of their disease. Thus, their first concern is how to stop the pain, rather than a child wish. In these women, child wish may only emerge after a “successful” removal of the endometriosis and pain reduction.
W
Disclosure: The authors declare no conflicts of interest and source of funding. C 2015 Wolters Kluwer Health, Inc. All Copyright rights reserved. ISSN: 0003-4932/15/26201-e0026 DOI: 10.1097/SLA.0000000000000426
e26 | www.annalsofsurgery.com
Even if there are evidences that radical surgery of DE nodules significantly improves pain symptoms, some debate remains as to the indication for surgery in patients with infertility. Finally, endometriomas often associated with DE nodules raise the issue of their concomitant surgical treatment before artificial reproductive technology (ART).4 However, this debate is somewhat confusing due to the wide range of clinical and anatomical variables of colon-rectal DE nodules including the degree of adnexa involvement, ovarian reserve, and surgeon skill. In addition, child wish of patients with DE nodules is too often treated separately by a surgeon or by a reproductive endocrinologist shifting “arbitrarily” the “successful” treatment toward surgery or ART. This might explain the contrasting data in literature and the presence of only few wellconducted studies. The study of Meuleman et al reflects dramatically the picture of a high-volume endometriosis referral center: 80% of women underwent surgery for pelvic pain and concomitant child wish and 70% of them had received 1, 2, or 3 previous “unsuccessful” surgical procedures for endometriosis. Meuleman et al showed that cumulative pregnancy rate was 44%, 58%, and 73% after 1, 2 and 3 years of surgery, respectively. Interestingly, 45% conceive spontaneously, although the concomitant presence of adnexal mass was 68%. This finding improves the existing literature that shows a rate of conception ranging from 39.4% to 46.2% after surgery, although studies have many differences for indications and surgical methods used.5 Recently, a prospective study by Donnez and Squifflet6 demonstrated an overall pregnancy rate of 84% (57% become pregnant naturally) in women operated on by shaving technique for DE nodules. These prospective studies have the merit of formalizing and confirming that surgery may be largely “successful” in restoring fertility in women in addition to alleviating their pain. “Successful” surgery for DE nodule surgery does not always mean “radical surgery” but a strategy that significantly improves the underestimated and inseparable concerns of many young women suffering endometriosis: pain and natural child wish. Unfortunately, many women still receive incomplete surgical procedures, often irrespective of ovarian reserve or repeated ART treatments in the presence of painful DE nodules. “Successful” surgery for endometriosis urgently needs standardization, methodology, adequate training, and quality control. Nicola Pluchino, MD, PhD Patrick Petignat, MD Jean-Marie Wenger, MD
Department of Obstetrics and Gynecology University of Geneva Geneva, Switzerland [email protected]
REFERENCES 1. Meuleman C, Tomassetti C, Wolthuis A, et al. Clinical outcome after radical excision of moderatesevere endometriosis with or without bowel resection and reanastomosis: a prospective cohort study. Ann Surg. 10 April 2013. [ePub ahead of print] 2. Nassif J, Trompoukis P, Barata S, et al. Management of deep endometriosis. Reprod Biomed Online. 2011;23:25–33. 3. Koninckx PR, Ussia A, Adamyan L, et al. Deep endometriosis: definition, diagnosis, and treatment. Fertil Steril. 2012;98:564–571. 4. Uncu G, Kasapoglu I, Ozerkan K, et al. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013;28:2140–2145. 5. Meuleman C, Tomassetti C, D’Hoore A, et al. Surgical treatment of deeply infiltrating endometriosis with colorectal involvement. Hum Reprod Update. 2011;17:311–312. 6. Donnez J, Squifflet J. Complications, pregnancy and recurrence in a prospective series of 500 patients operated on by the shaving technique for deep rectovaginal endometriotic nodules. Hum Reprod. 2010;25:1949–1958.
Reply:
W
e have read with great interest the letters by Pluchino and Roman in response to our article.1 We agree with Pluchino that most patients with deep endometriosis (DE) have combined pain and unfulfilled or uncompleted child wish primarily due to severe dyspareunia and inability to have sexual intercourse aimed at reproduction. In a population with complex recurrent DE, we demonstrated in 3 different studies1–4 that radical but fertility-sparing CO2 laser laparoscopic resection of moderate to severe endometriosis in a multidisciplinary setting resulted in a low complication rate, a low cumulative reintervention/recurrence rate, and a high cumulative pregnancy rate, also when bowel
Disclosure: Thomas D’Hooghe, Christel Meuleman, and Carla Tomassetti have been supported as clinical investigators by the Leuven University Hospital Clinical Research Foundation. Thomas D’Hooghe has also been funded as Fundamental Clinical Investigator by the Flemish Foundation for Scientific Research (FWO, Fonds voor Wetenschappelijk Onderzoek, Belgium). He has received grants from Ferring Pharmaceuticals, Merck Serono, and Besins and has been a consultant for several companies including Roche Diagnostics, Proteomika, Bayer, Astellas, Actavis (Uteron), Pharmaplex, Teva, Arresto, and Merck. For the remaining authors, no conflicts of interest were declared. 10.1097/SLA.0000000000000573
Annals of Surgery r Volume 262, Number 1, July 2015
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 1, July 2015
resection-reanastomosis was performed in women with colorectal endometriosis. For these women, excisional complete surgery can cure or reduce dyspareunia resulting in improvement or restoration of sexual function5 and allows spontaneous conception in about 50% of those with active child wish postoperatively1–4 instead of direct referral to treatment with assisted reproductive technology ignoring both pelvic pain and the patient’s right to conceive naturally. We also agree with Pluchino that this surgery should be done in a multidisciplinary center with combined expertise in laparoscopic surgery, coordinated by a senior gynecological surgeon in close collaboration with senior gastroenterological surgeons and urologists.4 In a systematic review6 to asses clinical outcome of surgical treatment of deeply infiltrative endometriosis with colorectal involvement, data were reported in such a way that comparison of different surgical techniques was not possible, but the total recurrence rate and the visually and/or histologically proven recurrence rate appeared to be lower in the bowel resection-reanastomosis group than in a mixed surgical control group. To find out which surgical technique is best for which specific clinical situation, to resolve difficulties in the assessment of endometriosis recurrences, and to make progress in surgery for DE, we agree with Roman that we need well-designed prospective trials. Therefore, we have published a CONSORT-based checklist to standardize reporting of pre-, per-, and postoperative data in surgical endometriosis research with standardized terms and definitions regarding patient phenotype, preoperative imaging, surgical techniques, complications, medicolegal cases, postoperative hormonal treatment, recurrences and outcomes related to pelvic pain (dysmenorrhea, dyspareunia, nonmenstrual pelvic pain), fertility (spontaneous or medically assisted reproduction), bowel function, bladder function, sexual function, and quality of life.4,6,7 This published checklist4,6 can now be used as a manual for the design of surgical trials in DE. However, comparison of the clinical outcome of different surgical techniques for DE is a major hurdle because of several reasons.4,6,7 First, in every study in the literature, the results of 1 or more surgeons are reported. Therefore, when comparing different studies, the quality of the different surgeons is compared and not the quality of the different techniques.6 Second, in symptomatic women with moderate to severe endometriosis, it is unethical to directly compare the clinical outcome of a given surgical technique with an untreated control group in view of the clinical outcome results achieved in cohort studies.4,6 Furthermore, direct comparison between 2 different techniques (discoid
resection vs resection-reanastomosis) for the surgery of DE in a monocenter-monosurgeon randomized trial, as proposed by Roman, is unreliable, because surgeons have their own surgical skills, opinions, and preferences,4,6,7 with the inherent bias that surgeons who believe that discoid resection is better than resection-reanastomosis are likely to be less surgically trained in resection-reanastomosis. In such trials, the role of the bowel surgeon is important and should be specified.4,6,7 In our opinion, a multicenter prospective cohort study is needed to compare the outcome of different surgical techniques/approaches in well-defined patient populations with DE based on clinical features and preoperative imaging and with standardized reports based on our checklist.4,6 Each surgeon could use his or her own preferred surgical technique to achieve the best possible results for each center, and the results between centers could be compared during a follow-up period of at least 2 years after surgery.4 Life table analysis, controlling for the duration of follow-up and dropout rate for each patient, should be used to calculate recurrence rates and pregnancy rates. Postoperative hormonal treatment and fertility treatment/pregnancy should be registered. We disagree with Roman that our article is based on inappropriate comparison: our patient population includes all consecutively operated patients with moderate to severe endometriosis and clearly demonstrates that clinical outcome was comparable between the group receiving bowel resection and the group not receiving bowel resection, rejecting the hypothesis from Roman and others that bowel resection-reanastomosis is always associated with high complication rates and poor clinical outcome. We agree with Roman that there is clinical heterogeneity between the study and control groups and explained in our article1 that this was inevitable because the decision to perform colorectal resection-reanastomosis was not taken before surgery, but during surgery, in a similar way for all patients of the study. Colorectal involvement per se was not an indication for intestinal resection-anastomosis.1 During surgery, the colorectal surgeon evaluated the integrity of the rectosigmoid colon and the rectum and decided, depending on the type of lesions and their extensions, whether or not to resect the involved segment with primary reanastomosis.1 The decision of bowel resection-reanastomosis was taken in the following conditions: large, direct, full-thickness trauma to the rectosigmoid too extensive to be sutured; extensive lesion to the bowel wall musculature in the absence of full-thickness damage but with impact on functionality; and extensive lateral dissection compromising the colorectal wall vascular-
C 2015 Wolters Kluwer Health, Inc. All rights reserved.
Letter to the Editor
ization and/or innervations.1 As a result of this decision-making process, bowel resectionreanastomosis was performed not only in 37% (n = 76/203) of all women with moderate to severe endometriosis, mostly in the subgroup with colorectal extension (n = 66/118; 56%), but also in 10 women without preoperatively documented colorectal extension.1 Using the same decision-making process, there was no indication for bowel resection-reanastomosis in the other 44% (n = 52/118) of women with endometriosis associated with colorectal involvement.1 Any bias introduced by clinical heterogeneity between both groups would have favored a worse clinical outcome in the study group than in the control group (higher major complication and reintervention rate; lower pain relief rate, pregnancy rate, and quality of life1 ). However, both groups had a comparable clinical outcome, except for a higher minor complication rate, which underscores our conclusion that surgical management of women with moderate to severe endometriosis with a surgical indication for bowel resection-reanastomosis can be effective and safe.1 In reply to Roman’s remark that there was a very low response rate in our study,1 we emphasize that the initial response rate was 83%, that all patients in our study were followed up personally, were seen or called at 6, 12, 18, and 24 months after surgery, as recommended by Roman, and that clinical outcome data were entered in our clinical files and database (recurrence/reintervention– pregnancy–postoperative medication) and used for analysis in our article,1 with separate results reported for the questionnaires, as mentioned in our article.1 To ensure the completeness of the study database, the information about complications, reintervention/recurrence, and fertility/pregnancy obtained from the postoperative questionnaires was systematically compared1 with the information from the electronic patient files and calculated taking into account the last date of contact with the patient (database closed on July 31, 2010). Inconsistency between the content of the electronic patient files and the patient responses in questionnaires was never observed,1 suggesting that the collection of data based on clinical contacts was reliable. The occurrence of pregnancy (n = 75) and the lack of pain symptoms (clinical file information) were the main reasons why the response rate of patients answering the questionnaire dropped over time at 18 and 24 months. At the end of the study, 93 patients were not pregnant and were either receiving fertility treatment or contraceptive hormonal treatment using a low-dose oral progestogen or combined contraceptive, or a levonorgestrel-releasing intrauterine device1 was prescribed (n = 31) to minimize menstruation. Therefore, the www.annalsofsurgery.com | e27
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 1, July 2015
Pluchino et al
clinical outcome reported in our study is valid. Christel Meuleman, MD, PhD Carla Tomassetti, MD (joint first author) Leuven University Fertility Center Department of Obstetrics and Gynaecology University Hospital Leuven Leuven, Belgium Albert Wolthuis, MD Department of Abdominal Surgery University Hospital Leuven Leuven, Belgium Ben Van Cleynenbreugel, MD Department of Urology University Hospital Leuven Leuven, Belgium Annouschka Laenen, PhD Interuniversity Centre for Biostatistics and Statistical Bioinformatics Leuven, Belgium University of Hasselt Hasselt, Belgium
e28 | www.annalsofsurgery.com
Andre D’Hoore, MD, PhD (joint last author) Department of Abdominal Surgery University Hospital Leuven Leuven, Belgium Thomas D’Hooghe, MD, PhD Leuven University Fertility Center Department of Obstetrics and Gynaecology University Hospital Leuven Leuven, Belgium Department of Development and Regeneration Behing University Hospital Leuven Group Biomedical Sciences KU Leuven (University of Leuven) Leuven, Belgium [email protected]
REFERENCES 1. Meuleman C, Tomassetti C, Wolthuis A, et al. Clinical outcome after radical excision of moderatesevere endometriosis with or without bowel resection and reanastomosis: a prospective cohort study. Ann Surg.10 April 2013. [ePub ahead of print]
2. Meuleman C, D’Hoore A, Van Cleynenbreugel B, et al. Outcome after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating colorectal endometriosis. Reprod Biomed Online. 2009;18:282–289. 3. Meuleman C, Tomassetti C, D’Hoore A, et al. Clinical outcome after CO2 laser laparoscopic radical excision of endometriosis with colorectal wall invasion combined with laparoscopic segmental bowel resection and reanastomosis. Hum Reprod. 2011;26:2336–2343. 4. Meuleman C, Tomassetti C, Van Cleyenbreugel B, et al. Clinical outcome after CO2 laser laparoscopic radical excision of endometriosis and laparoscopic segmental bowel resection. Curr Opin Obstet Gynecol. 2012;24:245–252. 5. Van den Broeck U, Meuleman C, Tomassetti C, et al. Effect of laparoscopic surgery for moderate and severe endometriosis on depression, relationship satisfaction and sexual functioning: comparison of patients with and without bowel resection. Hum Reprod. 2013;28:2389–2397. 6. Meuleman C, Tomassetti C, D’Hoore A, et al. Surgical treatment of deeply infiltrating endometriosis with colorectal involvement. Hum Reprod Update. 2011;17:311–326. 7. Meuleman C, D’Hoore A, Van Cleynenbreugel B, et al. Why we need international agreement on terms and definitions to assess clinical outcome after endometriosis surgery. Hum Reprod. 2011;26:1598– 1599.
C 2015 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
W
Disclosure: The authors declare no conflicts of interest and source of funding. C 2015 Wolters Kluwer Health, Inc. All Copyright rights reserved. ISSN: 0003-4932/15/26201-e0026 DOI: 10.1097/SLA.0000000000000426
e26 | www.annalsofsurgery.com
Even if there are evidences that radical surgery of DE nodules significantly improves pain symptoms, some debate remains as to the indication for surgery in patients with infertility. Finally, endometriomas often associated with DE nodules raise the issue of their concomitant surgical treatment before artificial reproductive technology (ART).4 However, this debate is somewhat confusing due to the wide range of clinical and anatomical variables of colon-rectal DE nodules including the degree of adnexa involvement, ovarian reserve, and surgeon skill. In addition, child wish of patients with DE nodules is too often treated separately by a surgeon or by a reproductive endocrinologist shifting “arbitrarily” the “successful” treatment toward surgery or ART. This might explain the contrasting data in literature and the presence of only few wellconducted studies. The study of Meuleman et al reflects dramatically the picture of a high-volume endometriosis referral center: 80% of women underwent surgery for pelvic pain and concomitant child wish and 70% of them had received 1, 2, or 3 previous “unsuccessful” surgical procedures for endometriosis. Meuleman et al showed that cumulative pregnancy rate was 44%, 58%, and 73% after 1, 2 and 3 years of surgery, respectively. Interestingly, 45% conceive spontaneously, although the concomitant presence of adnexal mass was 68%. This finding improves the existing literature that shows a rate of conception ranging from 39.4% to 46.2% after surgery, although studies have many differences for indications and surgical methods used.5 Recently, a prospective study by Donnez and Squifflet6 demonstrated an overall pregnancy rate of 84% (57% become pregnant naturally) in women operated on by shaving technique for DE nodules. These prospective studies have the merit of formalizing and confirming that surgery may be largely “successful” in restoring fertility in women in addition to alleviating their pain. “Successful” surgery for DE nodule surgery does not always mean “radical surgery” but a strategy that significantly improves the underestimated and inseparable concerns of many young women suffering endometriosis: pain and natural child wish. Unfortunately, many women still receive incomplete surgical procedures, often irrespective of ovarian reserve or repeated ART treatments in the presence of painful DE nodules. “Successful” surgery for endometriosis urgently needs standardization, methodology, adequate training, and quality control. Nicola Pluchino, MD, PhD Patrick Petignat, MD Jean-Marie Wenger, MD
Department of Obstetrics and Gynecology University of Geneva Geneva, Switzerland [email protected]
REFERENCES 1. Meuleman C, Tomassetti C, Wolthuis A, et al. Clinical outcome after radical excision of moderatesevere endometriosis with or without bowel resection and reanastomosis: a prospective cohort study. Ann Surg. 10 April 2013. [ePub ahead of print] 2. Nassif J, Trompoukis P, Barata S, et al. Management of deep endometriosis. Reprod Biomed Online. 2011;23:25–33. 3. Koninckx PR, Ussia A, Adamyan L, et al. Deep endometriosis: definition, diagnosis, and treatment. Fertil Steril. 2012;98:564–571. 4. Uncu G, Kasapoglu I, Ozerkan K, et al. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013;28:2140–2145. 5. Meuleman C, Tomassetti C, D’Hoore A, et al. Surgical treatment of deeply infiltrating endometriosis with colorectal involvement. Hum Reprod Update. 2011;17:311–312. 6. Donnez J, Squifflet J. Complications, pregnancy and recurrence in a prospective series of 500 patients operated on by the shaving technique for deep rectovaginal endometriotic nodules. Hum Reprod. 2010;25:1949–1958.
Reply:
W
e have read with great interest the letters by Pluchino and Roman in response to our article.1 We agree with Pluchino that most patients with deep endometriosis (DE) have combined pain and unfulfilled or uncompleted child wish primarily due to severe dyspareunia and inability to have sexual intercourse aimed at reproduction. In a population with complex recurrent DE, we demonstrated in 3 different studies1–4 that radical but fertility-sparing CO2 laser laparoscopic resection of moderate to severe endometriosis in a multidisciplinary setting resulted in a low complication rate, a low cumulative reintervention/recurrence rate, and a high cumulative pregnancy rate, also when bowel
Disclosure: Thomas D’Hooghe, Christel Meuleman, and Carla Tomassetti have been supported as clinical investigators by the Leuven University Hospital Clinical Research Foundation. Thomas D’Hooghe has also been funded as Fundamental Clinical Investigator by the Flemish Foundation for Scientific Research (FWO, Fonds voor Wetenschappelijk Onderzoek, Belgium). He has received grants from Ferring Pharmaceuticals, Merck Serono, and Besins and has been a consultant for several companies including Roche Diagnostics, Proteomika, Bayer, Astellas, Actavis (Uteron), Pharmaplex, Teva, Arresto, and Merck. For the remaining authors, no conflicts of interest were declared. 10.1097/SLA.0000000000000573
Annals of Surgery r Volume 262, Number 1, July 2015
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 1, July 2015
resection-reanastomosis was performed in women with colorectal endometriosis. For these women, excisional complete surgery can cure or reduce dyspareunia resulting in improvement or restoration of sexual function5 and allows spontaneous conception in about 50% of those with active child wish postoperatively1–4 instead of direct referral to treatment with assisted reproductive technology ignoring both pelvic pain and the patient’s right to conceive naturally. We also agree with Pluchino that this surgery should be done in a multidisciplinary center with combined expertise in laparoscopic surgery, coordinated by a senior gynecological surgeon in close collaboration with senior gastroenterological surgeons and urologists.4 In a systematic review6 to asses clinical outcome of surgical treatment of deeply infiltrative endometriosis with colorectal involvement, data were reported in such a way that comparison of different surgical techniques was not possible, but the total recurrence rate and the visually and/or histologically proven recurrence rate appeared to be lower in the bowel resection-reanastomosis group than in a mixed surgical control group. To find out which surgical technique is best for which specific clinical situation, to resolve difficulties in the assessment of endometriosis recurrences, and to make progress in surgery for DE, we agree with Roman that we need well-designed prospective trials. Therefore, we have published a CONSORT-based checklist to standardize reporting of pre-, per-, and postoperative data in surgical endometriosis research with standardized terms and definitions regarding patient phenotype, preoperative imaging, surgical techniques, complications, medicolegal cases, postoperative hormonal treatment, recurrences and outcomes related to pelvic pain (dysmenorrhea, dyspareunia, nonmenstrual pelvic pain), fertility (spontaneous or medically assisted reproduction), bowel function, bladder function, sexual function, and quality of life.4,6,7 This published checklist4,6 can now be used as a manual for the design of surgical trials in DE. However, comparison of the clinical outcome of different surgical techniques for DE is a major hurdle because of several reasons.4,6,7 First, in every study in the literature, the results of 1 or more surgeons are reported. Therefore, when comparing different studies, the quality of the different surgeons is compared and not the quality of the different techniques.6 Second, in symptomatic women with moderate to severe endometriosis, it is unethical to directly compare the clinical outcome of a given surgical technique with an untreated control group in view of the clinical outcome results achieved in cohort studies.4,6 Furthermore, direct comparison between 2 different techniques (discoid
resection vs resection-reanastomosis) for the surgery of DE in a monocenter-monosurgeon randomized trial, as proposed by Roman, is unreliable, because surgeons have their own surgical skills, opinions, and preferences,4,6,7 with the inherent bias that surgeons who believe that discoid resection is better than resection-reanastomosis are likely to be less surgically trained in resection-reanastomosis. In such trials, the role of the bowel surgeon is important and should be specified.4,6,7 In our opinion, a multicenter prospective cohort study is needed to compare the outcome of different surgical techniques/approaches in well-defined patient populations with DE based on clinical features and preoperative imaging and with standardized reports based on our checklist.4,6 Each surgeon could use his or her own preferred surgical technique to achieve the best possible results for each center, and the results between centers could be compared during a follow-up period of at least 2 years after surgery.4 Life table analysis, controlling for the duration of follow-up and dropout rate for each patient, should be used to calculate recurrence rates and pregnancy rates. Postoperative hormonal treatment and fertility treatment/pregnancy should be registered. We disagree with Roman that our article is based on inappropriate comparison: our patient population includes all consecutively operated patients with moderate to severe endometriosis and clearly demonstrates that clinical outcome was comparable between the group receiving bowel resection and the group not receiving bowel resection, rejecting the hypothesis from Roman and others that bowel resection-reanastomosis is always associated with high complication rates and poor clinical outcome. We agree with Roman that there is clinical heterogeneity between the study and control groups and explained in our article1 that this was inevitable because the decision to perform colorectal resection-reanastomosis was not taken before surgery, but during surgery, in a similar way for all patients of the study. Colorectal involvement per se was not an indication for intestinal resection-anastomosis.1 During surgery, the colorectal surgeon evaluated the integrity of the rectosigmoid colon and the rectum and decided, depending on the type of lesions and their extensions, whether or not to resect the involved segment with primary reanastomosis.1 The decision of bowel resection-reanastomosis was taken in the following conditions: large, direct, full-thickness trauma to the rectosigmoid too extensive to be sutured; extensive lesion to the bowel wall musculature in the absence of full-thickness damage but with impact on functionality; and extensive lateral dissection compromising the colorectal wall vascular-
C 2015 Wolters Kluwer Health, Inc. All rights reserved.
Letter to the Editor
ization and/or innervations.1 As a result of this decision-making process, bowel resectionreanastomosis was performed not only in 37% (n = 76/203) of all women with moderate to severe endometriosis, mostly in the subgroup with colorectal extension (n = 66/118; 56%), but also in 10 women without preoperatively documented colorectal extension.1 Using the same decision-making process, there was no indication for bowel resection-reanastomosis in the other 44% (n = 52/118) of women with endometriosis associated with colorectal involvement.1 Any bias introduced by clinical heterogeneity between both groups would have favored a worse clinical outcome in the study group than in the control group (higher major complication and reintervention rate; lower pain relief rate, pregnancy rate, and quality of life1 ). However, both groups had a comparable clinical outcome, except for a higher minor complication rate, which underscores our conclusion that surgical management of women with moderate to severe endometriosis with a surgical indication for bowel resection-reanastomosis can be effective and safe.1 In reply to Roman’s remark that there was a very low response rate in our study,1 we emphasize that the initial response rate was 83%, that all patients in our study were followed up personally, were seen or called at 6, 12, 18, and 24 months after surgery, as recommended by Roman, and that clinical outcome data were entered in our clinical files and database (recurrence/reintervention– pregnancy–postoperative medication) and used for analysis in our article,1 with separate results reported for the questionnaires, as mentioned in our article.1 To ensure the completeness of the study database, the information about complications, reintervention/recurrence, and fertility/pregnancy obtained from the postoperative questionnaires was systematically compared1 with the information from the electronic patient files and calculated taking into account the last date of contact with the patient (database closed on July 31, 2010). Inconsistency between the content of the electronic patient files and the patient responses in questionnaires was never observed,1 suggesting that the collection of data based on clinical contacts was reliable. The occurrence of pregnancy (n = 75) and the lack of pain symptoms (clinical file information) were the main reasons why the response rate of patients answering the questionnaire dropped over time at 18 and 24 months. At the end of the study, 93 patients were not pregnant and were either receiving fertility treatment or contraceptive hormonal treatment using a low-dose oral progestogen or combined contraceptive, or a levonorgestrel-releasing intrauterine device1 was prescribed (n = 31) to minimize menstruation. Therefore, the www.annalsofsurgery.com | e27
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 262, Number 1, July 2015
Pluchino et al
clinical outcome reported in our study is valid. Christel Meuleman, MD, PhD Carla Tomassetti, MD (joint first author) Leuven University Fertility Center Department of Obstetrics and Gynaecology University Hospital Leuven Leuven, Belgium Albert Wolthuis, MD Department of Abdominal Surgery University Hospital Leuven Leuven, Belgium Ben Van Cleynenbreugel, MD Department of Urology University Hospital Leuven Leuven, Belgium Annouschka Laenen, PhD Interuniversity Centre for Biostatistics and Statistical Bioinformatics Leuven, Belgium University of Hasselt Hasselt, Belgium
e28 | www.annalsofsurgery.com
Andre D’Hoore, MD, PhD (joint last author) Department of Abdominal Surgery University Hospital Leuven Leuven, Belgium Thomas D’Hooghe, MD, PhD Leuven University Fertility Center Department of Obstetrics and Gynaecology University Hospital Leuven Leuven, Belgium Department of Development and Regeneration Behing University Hospital Leuven Group Biomedical Sciences KU Leuven (University of Leuven) Leuven, Belgium [email protected]
REFERENCES 1. Meuleman C, Tomassetti C, Wolthuis A, et al. Clinical outcome after radical excision of moderatesevere endometriosis with or without bowel resection and reanastomosis: a prospective cohort study. Ann Surg.10 April 2013. [ePub ahead of print]
2. Meuleman C, D’Hoore A, Van Cleynenbreugel B, et al. Outcome after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating colorectal endometriosis. Reprod Biomed Online. 2009;18:282–289. 3. Meuleman C, Tomassetti C, D’Hoore A, et al. Clinical outcome after CO2 laser laparoscopic radical excision of endometriosis with colorectal wall invasion combined with laparoscopic segmental bowel resection and reanastomosis. Hum Reprod. 2011;26:2336–2343. 4. Meuleman C, Tomassetti C, Van Cleyenbreugel B, et al. Clinical outcome after CO2 laser laparoscopic radical excision of endometriosis and laparoscopic segmental bowel resection. Curr Opin Obstet Gynecol. 2012;24:245–252. 5. Van den Broeck U, Meuleman C, Tomassetti C, et al. Effect of laparoscopic surgery for moderate and severe endometriosis on depression, relationship satisfaction and sexual functioning: comparison of patients with and without bowel resection. Hum Reprod. 2013;28:2389–2397. 6. Meuleman C, Tomassetti C, D’Hoore A, et al. Surgical treatment of deeply infiltrating endometriosis with colorectal involvement. Hum Reprod Update. 2011;17:311–326. 7. Meuleman C, D’Hoore A, Van Cleynenbreugel B, et al. Why we need international agreement on terms and definitions to assess clinical outcome after endometriosis surgery. Hum Reprod. 2011;26:1598– 1599.
C 2015 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
