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

NCT04398641 | Unknown

• 1 other identifier: 2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Endometriosis, Rectum

Keywords

Bowel endometriosis; Deep endometriosis (DE); 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Prevalence of presurgical digestive complaints (LARS)

  1 day

• Prevalence of presurgical digestive complaints (GIQLI by Eypasch)

  1 day

Study Arms (2)

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

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

Interventions

Evaluation of pre- and postoperative gastrointestinal functional outcomes OTHER

Gastrointestinal functional outcomes will be evaluated using the LARS and the GIQLI by Eypasch questionnaires.

Nerve and vessel sparing segmental resection (NVSSR); Transanal disc excision (TADE)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.: lead

Study Sites (2)

Woman & Health Vienna

Vienna, 1010, Austria

RECRUITING

Hospital St. John of God Vienna

Vienna, 1020, Austria

RECRUITING

MeSH Terms

Conditions

Endometriosis; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gernot Hudelist, MD, MSc

  Woman & Health Private Clinic Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gernot Hudelist, MD, MSc

CONTACT

0043 1 5333 654; gernot.hudelist@womanandhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc Clinical Lecturer

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: July 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

AU (2)