Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain

Surgery for Deep Endometriosis of the Lower Rectum (Segmental/Disc) - a Prospective Comparison of Surgical Techniques Regarding Pre- and Postoperative Digestive Symptoms and Pain Outcomes

Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery with typical symptoms such as constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described as low anterior resection syndrome (LARS).

The primary aim of this study is the prospective comparison of two surgical approaches for full thickness excision, i.e. transanal disc excision (TADE) and nerve-vessel sparing limited segmental resection (NVSSR), regarding gastrointestinal functional outcomes using the LARS / Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaires.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis, Rectum
• Intervention / Treatment: Other: Evaluation of pre- and postoperative gastrointestinal functional outcomes

Detailed Description

Several studies show a significant drop in pain scores, improved fertility outcomes and amelioration of impaired sexual functioning in women following surgical resection of colorectal endometriosis. However, there is inceasing evidence that intermediate and long-term bowel dysfunction may occur as a consequence of radical surgery for rectal deep endometriosis (DE). Typical symptoms include constipation, feeling of incomplete evacuation, clustering of stools and urgency. This is described in the colorectal surgical literature as low anterior resection syndrome (LARS). The choice of operation is largely dependent on the extent of disease. Statistically significant differences in functional outcomes were found in favor of the conservative surgical approach, i.e. resection of endometriotic tissue with preservation of the luminal structure of the rectal wall thereby avoiding segmental bowel resection. In a recent retrospective multicentric cohort analysis, the incidence of LARS after either nerve and vessel sparing segmental resection (NVSSR) or transanal disc excision (TADE) performed for the surgical treatment of colorectal DE was assessed. All patients underwent a low rectum resection, with a resection line lower than 7cm from anal verge. In contrast to previoisly published data, no statistically significant difference between the incidence of the LARS among patients operated using TADE when compared to women treated by NVSSR were found. Interestingly, the occurence of LARS was positively associated with the use of protective ileo-or colostomy. A higher rate of severe complications was observed in the TADE group than among patients who underwent a NVSSR. Weaknesses of this study are the retrospective design and a possible bias in the TADE regarding larger DE nodules as well as the possibility of bowel dysfunction prior to surgery in women with DE.

The primary aim of the present study is the prospective comparison of two surgical approaches for full thickness excision of rectal DE resulting in an anastomotic height ≤7 cm distance from the anal verge. One technique involves the preservation of the residual luminal wall integrity (disc resection) known as Rouen technique/ TADE. The other technique involves limited resection of the bowel wall with preservation of all adjacent structures (autonomic pelvic plexus, rectal vascular supply) known as NVSSR. Gastrointestinal functional outcomes of the two procedures will be compared using the LARS / GIQLI by Eypasch questionnaires. Since digestive complaints may also be present presurgically, evaluation of digestive complaints will be recorded pre- and post surgery.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Gernot Hudelist, MD, MSc; Phone Number: 0043 1 5333 654; Email: gernot.hudelist@womanandhealth.com

Study Locations

• Austria
  • Vienna, Austria, 1010
    • Recruiting
    • Woman & Health Vienna
    • Contact: Gernot Hudelist, MD, MSc
  • Vienna, Austria, 1020
    • Recruiting
    • Hospital St. John of God Vienna
    • Contact: Gernot Hudelist, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge will be included in this study. These women will undergo either nerve and vessel sparing segmental resection (NVSSR) or transanal disc excision (TADE).

Description

Inclusion Criteria:

• Premenopausal women undergoing full thickness excision of rectal deep endometriosis (DE) resulting in an anastomotic height ≤7 cm distance from the anal verge

Exclusion Criteria:

• Diagnosed or suspected malignancy
• Previous colorectal surgery
• Previous history of chronic inflammatory diseases of the gastrointestinal tract and/or chronic defecation dysfunction related to other factors such as birth trauma etc.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nerve and vessel sparing segmental resection (NVSSR); Women undergoing surgery for deep endometriosis of the lower rectum using the surgical technique of nerve and vessel sparing segmental resection (NVSSR)	Other: Evaluation of pre- and postoperative gastrointestinal functional outcomes; Gastrointestinal functional outcomes will be evaluated using the LARS and the GIQLI by Eypasch questionnaires.
Transanal disc excision (TADE); Women undergoing surgery for deep endometriosis of the lower rectum using the surgical technique of transanal disc excision (TADE)	Other: Evaluation of pre- and postoperative gastrointestinal functional outcomes; Gastrointestinal functional outcomes will be evaluated using the LARS and the GIQLI by Eypasch questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of gastrointestinal functional outcomes between groups using the LARS questionnaire	Gastrointestinal functional outcomes in the nerve and vessel sparing segmental resection (NVSSR) group versus the transanal disc excision (TADE) group will be compared using the Low Anterior Resection Syndrome (LARS) questionnaire. LARS questionnaire: scores range from a minimum of 0 to a maximum of 42 points; higher scores mean a worse outcome	4 to 24 months
Comparison of gastrointestinal functional outcomes between groups using the GIQLI by Eypasch questionnaire	Gastrointestinal functional outcomes in the nerve and vessel sparing segmental resection (NVSSR) group versus the transanal disc excision (TADE) group will be compared using the Gastrointestinal Quality of Life Index (GIQLI) by Eypasch questionnaire. GIQLI by Eypasch questionnaire: scores range from a minimum of 0 to a maximum of 144 points; higher scores mean a better outcome	4 to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of presurgical digestive complaints (LARS)	The prevalence of presurgical digestive complaints assessed using the LARS questionnaire will be evaluated.	1 day
Prevalence of presurgical digestive complaints (GIQLI by Eypasch)	The prevalence of presurgical digestive complaints assessed using the GIQLI by Eypasch questionnaire will be evaluated.	1 day

Collaborators and Investigators

• Sponsor: Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.
• Investigators: Principal Investigator: Gernot Hudelist, MD, MSc, Woman & Health Private Clinic Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Deep endometriosis (DE); Bowel endometriosis; Transanal disc excision (TADE); Nerve and vessel sparing segmental resection (NVSSR); Low Anterior Resection Syndrome (LARS); Digestive complaints; Gastrointestinal Quality of Life Index (GIQLI) by Eypasch
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No