Mesenteric Sparing Surgery in Laparoscopic Colorectal Resection for Endometriosis

NCT03565848 | Unknown DMC

• 1 other identifier: IRE-1
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after surgery.

Conditions

Endometriosis; Bowel Endometriosis; Constipation

Keywords

Laparoscopy; Colorectal resection; Deep infiltrating endometriosis; Constipation

Outcome Measures

Primary Outcomes (6)

• Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain

  Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain

  Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery

• Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain

  Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain

  Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery

• Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain

  Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.

  Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery

• Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain

  Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.

  Change from baseline dysuria at 60 days after surgery and at 1 year after surgery

• Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain

  Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.

  Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery

• Change in bowel symptoms evaluated by Constipation Assessment Scale

  Bowel symptoms in 0 - 16 range according to the Constipation Assessment Scale. Constipation Assessment Scale includes eight items, each of which is self-rated by the patient as 'no problem' (score of 0), 'some problem' (score of 1), or 'severe problem' (score of 2). The item ratings are then summed, so the overall score may range from 0 (no constipation) to 16 (worst possible constipation).

  Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery

Secondary Outcomes (2)

• Endometriosis characteristics

  intraoperative

• Complication rate

  Within 6 months after surgery

Study Arms (1)

Women underwent colorectal resection for endometriosis

Women referred for colorectal resection for deep infiltrating endometriosis that underwent laparoscopic segmental colorectal resection performed with mesenteric vascular and nerve sparing surgery.

Procedure: Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection

Interventions

Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection PROCEDURE

Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.

Women underwent colorectal resection for endometriosis

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with deep infiltrating endometriosis underwent laparoscopic surgery treatment with segmental intestinal resection.

You may qualify if:

• Patients referred for bowel endometriosis requiring colorectal resection

You may not qualify if:

• None

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Conditions

Endometriosis; Constipation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simone Garzon, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà, M.D.

  Uninsubria

  PRINCIPAL INVESTIGATOR

• Paola Pomini, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Massimo Franchi, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

00393296279579; antoniosimone.lagana@asst-settelaghi.it

Simone Garzon

CONTACT

00393470782287; simone.garzon@univr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 21, 2018
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09