A Study on the Prognosis of Two Different Surgery Methods in Patients With Rectal Endometriosis

NCT06254716 | Recruiting

• 1 other identifier: FudanU2024-01-17
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study aims to compare the surgical and pregnancy outcomes of disc and segmental resection for rectal DIE through a single-center retrospective analysis, to summarize clinical experience, and to explore the possible factor of the differences. The results would provide preliminary clinical basis for the treatment and selection of surgical methods for patients with rectal DIE, and also provide a research basis for the prospective clinical studies.

Conditions

Gastrointestinal Function; Quality of Life; Pregnancy Outcomes

Keywords

rectal endometriosis; disc resection; segmental resection; anastomose; gastrointestinal function

Outcome Measures

Primary Outcomes (3)

• complication rate of surgery

  rate of rectovaginal fistula or anastomotic fistula

  one year after surgery

• gastrointestinal function

  The scoring of lower anterior resection syndrome (lower anterior resection syndrome

  one year after surgery

• recurrence rate

  Recurrence rate of symptoms or image findings

  one year after surgery

Secondary Outcomes (2)

• gastrointestinal function- related quality of life index

  one year after surgery

• pregnancy outcome

  one year after surgery

Study Arms (2)

Disc resection of rectal endometriosis

Patients who underwent disc resection and anastomosis for rectal endometriosis involving the full thickness of the rectum reaching the mucosa or submucosa during preoperative evaluation or intraoperative exploration, and who were diagnosed pathologically.

Procedure: disc resection

Segmental resection of rectal endometriosis

Patients who underwent segmental resection and anastomosis for rectal endometriosis involving the full thickness of the rectum reaching the mucosa or submucosa during preoperative evaluation or intraoperative exploration, and who were diagnosed pathologically.

Procedure: segmental resection

Interventions

disc resection PROCEDURE

disc resection refers to the full-thickness resection of the lesion and the intestinal wall, usually anterior rectal wall. During the operation, the anterior intestinal wall is opened and then sutured or anastomosed with a stapler. Segmental bowel resection for the treatment of intestinal endometriosis was first reported by Redwine and Sharpe in 1991, which requires the maximum removal of endometriosis lesions.

Disc resection of rectal endometriosis

segmental resection PROCEDURE

Segmental bowel resection for the treatment of intestinal endometriosis was first reported by Redwine and Sharpe in 1991, which requires the maximum removal of endometriosis lesions.

Segmental resection of rectal endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient age, body mass index, menstrual status (menstrual period, cycle, menstrual volume), reproductive history, pain symptoms and extent (dysmenorrhea, dyspareunia), intestinal symptoms (constipation, diarrhea, anal incontinence and blood in the stool) , history of infertility, polycystic ovary syndrome, abdominal surgery history (number of surgeries and endometriosis-related surgeries), imaging evaluation (ultrasound and magnetic resonance evaluation results: adenomyosis, ovarian uterus Endometriosis cysts, organs involved in deep endometriosis, location, size, number, depth of rectal lesions and circumference of the intestinal tube involved), colonoscopy evaluation results

You may qualify if:

• Patients who underwent surgery of disc and segmental resection followed by anastomosis for endometriosis
• Endometriosis involving the full thickness of the rectum reaching the mucosa or submucosa during preoperative evaluation or intraoperative exploration, and who were diagnosed pathologically.

You may not qualify if:

• Patients who have previously undergone surgical treatment of rectal endometriosis
• Patients with insufficient preoperative evaluation (lack of pelvic imaging evaluation or colonoscopy evaluation) and surgical removal of lesions;
• Postoperative pathology shows rectal mucosa or The submucosa is not involved; patients with malignant tumors.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

OB & GYN Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Wei Zhang, Ph.D.

  OB & GYN Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Hexia Xia, M.D.

CONTACT

+8613601843476; hexia_xia@fudan.edu.cn

Rongmin Wang, M.M.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 12, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CN (1)