EndometriosisNOSERESNCT04109378
The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
A study testing Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE in people with Endometriosis and Quality of Life, run by Semmelweis University at 1 site in Hungary.
Trial summary
Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Quality of Life
- What is being tested?
- Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2019to 23 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 45 years (both inclusive)
- 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
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Suspected pelvic malignancy
- Pregnancy
- Patients without bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. In cases of colorectal DIE, adequate therapy depends on the depth of infiltration and the size of the lesion as well as the woman's quality of life. Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique .
The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.
Read the detailed description
Endometriosis is an enigmatic disease affecting 6-10% of women of reproductive age or 176 millions of women worldwide (1). Endometriosis is defined as the presence of endometrial-like tissue outside the uterus and it induces a chronic inflammatory reaction (2). Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis (described by the invasion of anatomical structures and organs deeper than 5 mm beyond the peritoneum) and is present in 20-35% of all women suffering from the disease (3). Intestinal deep infiltrating endometriosis is known as lesions infiltrating at least the muscular layer of the bowel wall and most commonly affects the rectum, sigmoid colon and the rectovaginal septum. (4).
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
- Endometriosis, Quality of Life
- Being tested
- Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
- Keywords
- Fertility, Colorectal endometriosis, Surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIEProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients operated with conventional laparoscopic technique | Active comparator | Patients operated with conventional laparoscopic technique for colorectal DIE Receives: Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE |
| Patients operated with NOSE laparoscopic technique | Active comparator | Patients operated with NOSE technique for colorectal DIE Receives: Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis Health Profile, EHP 30
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.
The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.
Impact of surgical technique on the quality of life. The outcome will be assessed using validated electronic questionnaires containing questions from Endometriosis Health Profile 30. This is a core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being, social support, and self-image) contains a total of 30 items. (10)
Measured: 24 months
Gastrointestinal Quality of Life Index, GIQLI
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.
The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.
GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice of patients with gastrointestinal disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life. (11)
Measured: 24 months
LARS score before and after colorectal resection for DIE
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.
The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.
The Low Anterior Resection Syndrome (LARS) is a common complication that occures after colorectal surgery. The LARS score is a simple self-administered questionnaire measuring bowel dysfunction after rectal surgery. Contains questions regarding incontinence, emptying difficulties, urgency, and frequency. The calculated score ranges from 0 to 42, with a score of 0-20 representing no LARS, a score of 21-29 representing minor LARS and a score of 30-42 representing major LARS. (12)
Measured: 24 months
Endometriosis related pain before and after colorectal resection for DIE
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.
The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.
For the assessment of pre- and postoperative pain a Visual Analogue Scale is used (from 1-10, where 1 is the lowest and 10 is the maximum score) to assess the pre- and postoperative quality of life (dysmenorrhoea, dyspareunia, dyschezia, dysuria, CPP) (13).
Measured: 24 months
Infertility outcomes after colorectal resection for bowel endometriosis
Number of pregnancies, cumulative pregnancy rate and take home baby rate after laparoscopic bowel resection.
Measured: 24 months
Psychological questionnaires:
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum.
The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months.
Pain catastrophizing Scale, Self-Efficacy for Managing Chronic Disease 6-item Scale to investigate the psychological aspect of the disease (14,15).
Measured: 24 months
Secondary outcomes (3)
Complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis
To measure the complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis. The complication rates between the NOSE vs conventional specimen extraction technique will be examined. The difference between the complication rates will be presented according to Clavien-Dindo Classification System (16).
As follows:
Grade I Any deviation from the normal postoperative course without treatment by invasive interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III
Requiring surgical, endoscopic or radiological intervention
- IIIa
Intervention not under general anesthesia
- IIIb
Intervention under general anesthesia Grade IV
Life-threatening complication requiring IC/ICU-management
- IVa single organ dysfunction (including dialysis)
- IVb multiorgan dysfunction Grade V Death of a patient
Measured: 24 months
Hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis
To measure the hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis
Measured: 24 months
Lenght of recovery after colorectal resection performed for the treatment of bowel endometriosis
To measure the lenght of recovery after bowel resection will be assessed by the comparison of the hospital stay (mean +/- SD days)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Sep 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study was designed as a two-arm prospective randomized trial where all cases will be executed unblindly. As an experimental clinical trial the cases have been managed independently where the applied measures were computer based randomization. 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Attila Bokor, MD, PhD, Study director, Semmelweis UniversityNoemi Dobo, MD, Study chair, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109378
- Sponsor's protocol ID
- SemmlweisU
- Acronym
- NOSERES
- Status last verified
- May 2022
- First submitted
- 26 Aug 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will individual participant data will be available (including datadictionaires)? Individual participant data will be available. What data in particular will be shared? Individual participant data that underline the results reported in the article after deidentification (text, tables, figures and appendices) will be shared. What other documents will be available? Study protocol, statistical analysis plan, analytic code will be available as well. When will data be available (start and end dates)? Data will be available from 3 months to 5 years after the publication of the article. With whom? The data will be shared with researchers who provide a methodologically sound proposal. For what types of analysis? To achieve aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to attila.z.bokor@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
Publications
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.
PubMed 22422778Kennedy 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.
PubMed 15980014Wolthuis 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.
PubMed 24485255Meuleman 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.
PubMed 21233128Kossi 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.
PubMed 22642851Roman 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.
PubMed 29194531Ng 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.
PubMed 27297610Bokor 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.
PubMed 29454144Hudelist 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.
PubMed 30080244Jones 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.
PubMed 11506842Eypasch 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.
PubMed 7749697Emmertsen 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.
PubMed 22504191Bourdel 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.
PubMed 25180023Lorig 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.
PubMed 11769298Dindo 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.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
- ClinicalTrials.gov ID
- NCT04109378
- Acronym / sponsor ID
- NOSERES / SemmlweisU
- Conditions
- Endometriosis, Quality of Life
- Keywords
- Fertility, Colorectal endometriosis, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. In cases of colorectal DIE, adequate therapy depends on the depth of infiltration and the size of the lesion as well as the woman's quality of life. Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique .
The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.
Detailed description
Endometriosis is an enigmatic disease affecting 6-10% of women of reproductive age or 176 millions of women worldwide (1). Endometriosis is defined as the presence of endometrial-like tissue outside the uterus and it induces a chronic inflammatory reaction (2). Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis (described by the invasion of anatomical structures and organs deeper than 5 mm beyond the peritoneum) and is present in 20-35% of all women suffering from the disease (3). Intestinal deep infiltrating endometriosis is known as lesions infiltrating at least the muscular layer of the bowel wall and most commonly affects the rectum, sigmoid colon and the rectovaginal septum. (4).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our study was designed as a two-arm prospective randomized trial where all cases will be executed unblindly. As an experimental clinical trial the cases have been managed independently where the applied measures were computer based randomization. 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.
| Arm | Type | Receives |
|---|---|---|
| Patients operated with conventional laparoscopic technique | Active comparator | Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIEPatients operated with conventional laparoscopic technique for colorectal DIE |
| Patients operated with NOSE laparoscopic technique | Active comparator | Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIEPatients operated with NOSE technique for colorectal DIE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 - 45 years (both inclusive)
- Complaining of infertility and/or pain
- Deep endometriosis infiltrating the rectum on at least one imaging technique or confirmed by previous surgery
Key exclusion criteria (4 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Suspected pelvic malignancy
- Pregnancy
- Patients without bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIEFor 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 | Procedure or surgery | Patients operated with NOSE laparoscopic technique, Patients operated with conventional laparoscopic technique |
Primary outcome
Endometriosis Health Profile, EHP 30
Time frame: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. Impact of surgical technique on the quality of life. The outcome will be assessed using validated electronic questionnaires containing questions from Endometriosis Health Profile 30. This is a core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being, social support, and self-image) contains a total of 30 items. (10)
Gastrointestinal Quality of Life Index, GIQLI
Time frame: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice of patients with gastrointestinal disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life. (11)
LARS score before and after colorectal resection for DIE
Time frame: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. The Low Anterior Resection Syndrome (LARS) is a common complication that occures after colorectal surgery. The LARS score is a simple self-administered questionnaire measuring bowel dysfunction after rectal surgery. Contains questions regarding incontinence, emptying difficulties, urgency, and frequency. The calculated score ranges from 0 to 42, with a score of 0-20 representing no LARS, a score of 21-29 representing minor LARS and a score of 30-42 representing major LARS. (12)
Endometriosis related pain before and after colorectal resection for DIE
Time frame: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. For the assessment of pre- and postoperative pain a Visual Analogue Scale is used (from 1-10, where 1 is the lowest and 10 is the maximum score) to assess the pre- and postoperative quality of life (dysmenorrhoea, dyspareunia, dyschezia, dysuria, CPP) (13).
Infertility outcomes after colorectal resection for bowel endometriosis
Time frame: 24 months
Number of pregnancies, cumulative pregnancy rate and take home baby rate after laparoscopic bowel resection.
Psychological questionnaires:
Time frame: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. Pain catastrophizing Scale, Self-Efficacy for Managing Chronic Disease 6-item Scale to investigate the psychological aspect of the disease (14,15).
3 secondary outcomes
Complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis
Time frame: 24 months
Hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis
Time frame: 24 months
Lenght of recovery after colorectal resection performed for the treatment of bowel endometriosis
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 22422778Simoens 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.
- Background: PubMed 15980014Kennedy 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.
- Background: PubMed 24485255Wolthuis 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.
- Background: PubMed 21233128Meuleman 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.
- Background: PubMed 22642851Kossi 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.
- Background: PubMed 29194531Roman 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.
- Background: PubMed 27297610Ng 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.
- Background: PubMed 29454144Bokor 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.
- Background: PubMed 30080244Hudelist 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.
- Background: PubMed 11506842Jones 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.
- Background: PubMed 7749697Eypasch 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.
- Background: PubMed 22504191Emmertsen 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.
- Individual participant dataSharing planned: Yes. Will individual participant data will be available (including datadictionaires)? Individual participant data will be available. What data in particular will be shared? Individual participant data that underline the results reported in the article after deidentification (text, tables, figures and appendices) will be shared. What other documents will be available? Study protocol, statistical analysis plan, analytic code will be available as well. When will data be available (start and end dates)? Data will be available from 3 months to 5 years after the publication of the article. With whom? The data will be shared with researchers who provide a methodologically sound proposal. For what types of analysis? To achieve aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to attila.z.bokor@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attila Bokor, MD, PhD study director
Semmelweis University
Noemi Dobo, MD study chair
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE in people with Endometriosis and Quality of Life, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis Health Profile, EHP 30 (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109378, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.