The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
NCT ID: NCT04109378
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2019-09-01
2021-03-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Study of the Outcomes of the Surgical Treatment of Deeply Infiltrating Endometriosis
NCT01105897
Incidence of Different Surgical Technics for Colorectal Deep Infiltrating EndoMetriosis on the Post-operative Fertility and Pregnancy Outcomes
NCT04681898
The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
NCT05677269
Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis
NCT03565848
Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis
NCT00462176
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Even if bowel endometriosis may be totally asymptomatic, in many patients intestinal wall DIE alters significantly quality of life by provoking constipation, diarrhea, hematochezia, intestinal cramping, abdominal bloating, intestinal stenosis or obstruction and pain of defecation (5, 6). Rectal fixation to adjacent structures results in angulation of the rectum and subsequent defecatory pain and constipation. Fibrosis of nodules can lead to rectal constriction and stenosis, cyclical inflammation of the rectal wall may lead to changes in bowel habit (usually diarrhoea) with or without rectal bleeding (7).
Although the surgical laparoscopic management of endometriosis is widely accepted, the optimal type of resection, whether conservative approach (shaving, disc resection) or radical technique (involves limited resection of the bowel wall with preservation of all adjacent structures-autonomic pelvic plexus, rectal vascular supply- known as "nerve-vessel sparing limited segmental resection"), is under discussion for treatment of deep endometriosis infiltrating the rectum.
In cases of colorectal DIE, adequate therapy depends on the precise location, extent of the nodule and depth of invasion, as well as the woman's quality of life (3). Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy (conventional method) or by the natural orifice specimen extraction (NOSE) technique. (8).
The conventional method raises concerns because this could disrupt the integrity of the abdominal wall. Moreover, extraction site laparotomy is associated with higher postoperative pain scores. The occurrence of particular complications such as incisional hernias and wound infections is also higher than after conventional laparoscopic procedures (8).
In order to avoid these complications, NOSE technique has been introduced. During NOSE colectomy the specimen is extracted through a natural orifice and an intracorporeal anastomosis is performed (8).
Several studies have demonstrated a significant drop in pain scores and amelioration of impaired sexual functioning and improved pregnancy rates in women following surgical resection of colorectal endometriosis (9).
The aim of this study is to report the short, medium and long-term bowel functional outcomes and improvement of infertility, quality of life in women undergoing conventional and NOSE segmental bowel resection for endometriosis at our institution using validated questionnaires.
Functional and psychological outcomes will be assessed using different questionnaires at baseline and postoperative follow-up moments.
* Endometriosis Health Profile, EHP 30 (10)
* Gastrointestinal Quality of Life Index, GIQLI (11)
* Low Anterior Resection Syndrome score, LARS (12)
* Assessment of endometriosis related pain: Visual Analog Scale (13)
* Psychological questionnaires: Pain catastrophizing Scale (14), Self-Efficacy for Managing Chronic Disease 6-item Scale (15).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
In addition clustering effect has been examined within the two groups. The statistical power will be calculated for a sample size.
Randomization: Blinding in our study is not feasible.
Assignment of a patient to conventional or NOSE-colorectal resection is based on a randomization list using the simple randomization method. In order to determine the allocation sequence a computer based (www.random.org) coin flipping is carried out by a staff member with no clinical involvement in the study. The randomization will start after the patient had completed all baseline assessments and had given written consent to be enrolled in the trial.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients operated with conventional laparoscopic technique
Patients operated with conventional laparoscopic technique for colorectal DIE
Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
For conventional laparoscopic and NOSE techniques a 4-port approach is used. The rectum is skeletonized. The distal rectum is closed using an endoscopic linear stapler. The mobilized rectum with the specimen is retrieved through a small suprapubic incision. The anvil of a conventional circular stapler is introduced in the proximal colon after placement of a purse string suture. A circular stapled colorectal anastomosis is fired. In case of NOSE, both the proximal sigmoid colon and the proximal rectum are tied off laparoscopically with a nonabsorbable suture. A transverse colotomy is performed in healthy tissue using a harmonic scalpel to deliver the anvil from a circular stapler introduced through the anus. The specimen is extracted transrectally in a specimen retrieval bag. Proximal part of the anastomosis is completed by suturing the anvil in place with a laparoscopic suture. The distal rectum is closed using a linear stapler. End-to-end anastomosis is made using the circular stapler
Patients operated with NOSE laparoscopic technique
Patients operated with NOSE technique for colorectal DIE
Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
For conventional laparoscopic and NOSE techniques a 4-port approach is used. The rectum is skeletonized. The distal rectum is closed using an endoscopic linear stapler. The mobilized rectum with the specimen is retrieved through a small suprapubic incision. The anvil of a conventional circular stapler is introduced in the proximal colon after placement of a purse string suture. A circular stapled colorectal anastomosis is fired. In case of NOSE, both the proximal sigmoid colon and the proximal rectum are tied off laparoscopically with a nonabsorbable suture. A transverse colotomy is performed in healthy tissue using a harmonic scalpel to deliver the anvil from a circular stapler introduced through the anus. The specimen is extracted transrectally in a specimen retrieval bag. Proximal part of the anastomosis is completed by suturing the anvil in place with a laparoscopic suture. The distal rectum is closed using a linear stapler. End-to-end anastomosis is made using the circular stapler
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
For conventional laparoscopic and NOSE techniques a 4-port approach is used. The rectum is skeletonized. The distal rectum is closed using an endoscopic linear stapler. The mobilized rectum with the specimen is retrieved through a small suprapubic incision. The anvil of a conventional circular stapler is introduced in the proximal colon after placement of a purse string suture. A circular stapled colorectal anastomosis is fired. In case of NOSE, both the proximal sigmoid colon and the proximal rectum are tied off laparoscopically with a nonabsorbable suture. A transverse colotomy is performed in healthy tissue using a harmonic scalpel to deliver the anvil from a circular stapler introduced through the anus. The specimen is extracted transrectally in a specimen retrieval bag. Proximal part of the anastomosis is completed by suturing the anvil in place with a laparoscopic suture. The distal rectum is closed using a linear stapler. End-to-end anastomosis is made using the circular stapler
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Complaining of infertility and/or pain
* Deep endometriosis infiltrating the rectum on at least one imaging technique or confirmed by previous surgery
* up to 15 cm from the anus
* Involving at least the muscularis layer in depth
Exclusion Criteria
* Suspected pelvic malignancy
* Pregnancy
* Patients without bowel resection
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Semmelweis University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Attila Bokor, MD, PhD
Role: STUDY_DIRECTOR
Semmelweis University
Noemi Dobo, MD
Role: STUDY_CHAIR
Semmelweis University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Semmelweis University
Budapest, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Simoens S, Dunselman G, Dirksen C, Hummelshoj L, Bokor A, Brandes I, Brodszky V, Canis M, Colombo GL, DeLeire T, Falcone T, Graham B, Halis G, Horne A, Kanj O, Kjer JJ, Kristensen J, Lebovic D, Mueller M, Vigano P, Wullschleger M, D'Hooghe T. The burden of endometriosis: costs and quality of life of women with endometriosis and treated in referral centres. Hum Reprod. 2012 May;27(5):1292-9. doi: 10.1093/humrep/des073. Epub 2012 Mar 14.
Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. doi: 10.1093/humrep/dei135. Epub 2005 Jun 24.
Wolthuis AM, Tomassetti C. Multidisciplinary laparoscopic treatment for bowel endometriosis. Best Pract Res Clin Gastroenterol. 2014 Feb;28(1):53-67. doi: 10.1016/j.bpg.2013.11.008. Epub 2013 Dec 2.
Meuleman C, Tomassetti C, D'Hoore A, Van Cleynenbreugel B, Penninckx F, Vergote I, D'Hooghe T. Surgical treatment of deeply infiltrating endometriosis with colorectal involvement. Hum Reprod Update. 2011 May-Jun;17(3):311-26. doi: 10.1093/humupd/dmq057. Epub 2011 Jan 13.
Kossi J, Setala M, Makinen J, Harkki P, Luostarinen M. Quality of life and sexual function 1 year after laparoscopic rectosigmoid resection for endometriosis. Colorectal Dis. 2013 Jan;15(1):102-8. doi: 10.1111/j.1463-1318.2012.03111.x.
Roman H, Bubenheim M, Huet E, Bridoux V, Zacharopoulou C, Darai E, Collinet P, Tuech JJ. Conservative surgery versus colorectal resection in deep endometriosis infiltrating the rectum: a randomized trial. Hum Reprod. 2018 Jan 1;33(1):47-57. doi: 10.1093/humrep/dex336.
Ng A, Yang P, Wong S, Vancaillie T, Krishnan S. Medium to long-term gastrointestinal outcomes following disc resection of the rectum for treatment of endometriosis using a validated scoring questionnaire. Aust N Z J Obstet Gynaecol. 2016 Aug;56(4):408-13. doi: 10.1111/ajo.12476. Epub 2016 Jun 14.
Bokor A, Lukovich P, Csibi N, D'Hooghe T, Lebovic D, Brubel R, Rigo J. Natural Orifice Specimen Extraction during Laparoscopic Bowel Resection for Colorectal Endometriosis: Technique and Outcome. J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1065-1074. doi: 10.1016/j.jmig.2018.02.006. Epub 2018 Feb 14.
Hudelist G, Aas-Eng MK, Birsan T, Berger F, Sevelda U, Kirchner L, Salama M, Dauser B. Pain and fertility outcomes of nerve-sparing, full-thickness disk or segmental bowel resection for deep infiltrating endometriosis-A prospective cohort study. Acta Obstet Gynecol Scand. 2018 Dec;97(12):1438-1446. doi: 10.1111/aogs.13436. Epub 2018 Sep 16.
Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001 Aug;98(2):258-64. doi: 10.1016/s0029-7844(01)01433-8.
Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.
Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.
Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Guerriero S, Condous G, van den Bosch T, Valentin L, Leone FP, Van Schoubroeck D, Exacoustos C, Installe AJ, Martins WP, Abrao MS, Hudelist G, Bazot M, Alcazar JL, Goncalves MO, Pascual MA, Ajossa S, Savelli L, Dunham R, Reid S, Menakaya U, Bourne T, Ferrero S, Leon M, Bignardi T, Holland T, Jurkovic D, Benacerraf B, Osuga Y, Somigliana E, Timmerman D. Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms, definitions and measurements: a consensus opinion from the International Deep Endometriosis Analysis (IDEA) group. Ultrasound Obstet Gynecol. 2016 Sep;48(3):318-32. doi: 10.1002/uog.15955. Epub 2016 Jun 28.
Dobo N, Marki G, Hudelist G, Csibi N, Brubel R, Acs N, Bokor A. Laparoscopic natural orifice specimen extraction colectomy versus conventional laparoscopic colorectal resection in patients with rectal endometriosis: a randomized, controlled trial. Int J Surg. 2023 Dec 1;109(12):4018-4026. doi: 10.1097/JS9.0000000000000728.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SemmlweisU
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.