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AzTrials

Gastrointestinal FunctionNCT06254716

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

An observational study of Gastrointestinal Function and Quality of Life, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
disc resection and segmental resection
Type of treatment
Surgery or procedure
How many people
90 participants
Where
1 siteChina
Study dates
1 Jan 2024to 31 Dec 2024
Phase
Observational
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 50 years
  • Women only
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Rongmin Wang, M.M. contact

China1 site, 1 recruiting
  • OB & GYN Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200011

    Hexia Xia, M.D., +8613601843476

    Recruiting

Other trials in China

About this study

Official title: A Retrospective Single-center Cohort Study on the Prognosis of Disc Resection and Segmental Resection Followed by Anastomosis on Gastrointestinal Function and Quality of Life in Patients With Rectal Endometriosis

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.

Read the detailed description
  1. Research objectives This 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, to explore the possible factor of the differences and to followed up on the fertility outcomes of those who desire for pregnancy. 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.
  2. Innovation points In this retrospective study, innovation points are to compare the disease relief, perioperative complications and recurrence of two different surgical methods, disc resection and segmental resection, for rectal DIE involving the rectal mucosa and submucosa, and summarize past clinical experience. In order to provide preliminary clinical basis for the treatment and selection of surgical methods for patients with rectal DIE.
  3. Research the main content This project intends to conduct a retrospectively observational study to collect the clinical data of patients with rectal DIE who underwent disc resection and segmental resection in a single center, to analyze perioperative complications, and to follow up the patients' symptom relief and recurrence. For those who desire for fertility, follow up their fertility status and pregnancy outcomes. By summarizing past clinical experience and exploring the possible influencing factors of the differences, we hope to provide preliminary clinical basis for the treatment and selection of surgical methods for patients with rectal DIE.
  4. Key research methods and technologies:

Research methods: Single-center retrospective study

  1. Case collection: Collect patients who were hospitalized in the Obstetrics and Gynecology Hospital of Fudan University in Shanghai from 2018 to 2023 and received surgical treatment for rectal endometriosis. Inclusion criteria: Patients who underwent surgery for endometriosis and were found to have endometriosis involving the full thickness of the rectum reaching the mucosa or submucosa during preoperative evaluation or intraoperative exploration, and who were diagnosed pathologically. Exclusion criteria: 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.
  2. Case information collection: 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, preoperative hormone treatment status and time (GnRHa , oral short-acting contraceptives, Mirena, dienogest, progesterone, etc.), tumor markers (CA125, CA199, CEA, etc.), AMH and preoperative hemoglobin, surgical methods (open, traditional laparoscopy, single hole laparoscopy), surgical method of rectal lesion resection (butterfly resection and segmental resection), anastomosis method (suture, stapler), distance from the lesion to the anus, size of the resected lesion (diameter, depth and circumference) , surgical content (hysterectomy, ovarian resection, and other endometriosis surgeries), operation time and amount of bleeding.
  3. Surgical outcomes: decrease in hemoglobin, postoperative fever (whether ≥38°C), postoperative infection (pathogens confirmed by culture), perioperative blood transfusion treatment, postoperative complications (rectovaginal fistula, anastomotic fistula, Pelvic hematoma, urinary retention, organ damage, bleeding and multiple surgeries), postoperative hospitalization time, pathology (diameter, depth and circumference), postoperative auxiliary medication regimen and time (GnRHa, oral short-acting contraceptive pills , Mirena, dienogest, progesterone, etc.).
  4. Pregnancy-related: whether there is a desire to get pregnant; the time to prepare for pregnancy after surgery; whether there are male infertility factors; pregnancy outcomes (pregnancy interval, natural conception rate, assisted reproduction pregnancy rate, miscarriage rate, pregnancy rate).
  5. Recurrence: symptom assessment (pain level using VAS score and intestinal function recovery: frequency of defecation, stool shape, defecation pain, defecation effort) and imaging recurrence (magnetic resonance imaging shows lesions in the rectum).
  6. Follow-up method: Obtain preliminary results through outpatient electronic medical records; telephone follow-up for patient symptom assessment.
  7. Data analysis: Use SPSS software for data analysis. In descriptive statistics, categorical variables are expressed as numbers (percentages), and continuous variables are expressed as mean ± standard deviation. The t test was used to compare continuous variables between groups with normal distribution; the Mann-Whitney U test was used to compare continuous variables between groups with skewed distribution; the chi-square test was used to compare categorical variables between groups. The K-M curve plots postoperative recurrence and postoperative pregnancy. p<0.05 is considered to be statistically significant.
Being tested
disc resection, segmental resection
Keywords
rectal endometriosis, disc resection, segmental resection, anastomose, gastrointestinal function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • disc resectionProcedure or surgery

    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.

  • segmental resectionProcedure or surgery

    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.

Study groups in NCT06254716
Study groupRoleWhat they receive
Disc resection of rectal endometriosisPatients 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.
Receives: Procedure: disc resection
Segmental resection of rectal endometriosisPatients 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.
Receives: Procedure: segmental resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complication rate of surgery

    rate of rectovaginal fistula or anastomotic fistula

    Measured: one year after surgery

  2. gastrointestinal function

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

    Measured: one year after surgery

  3. recurrence rate

    Recurrence rate of symptoms or image findings

    Measured: one year after surgery

Secondary outcomes (2)
  1. gastrointestinal function- related quality of life index

    gastrointestinal function- related quality of life index, Gastrointestinal function- related quality of Life Index, GIQLI, visual analogue scale (VAS) and endometriosis health profile (EHP-30).

    Measured: one year after surgery

  2. pregnancy outcome

    natural conception rate

    Measured: one year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06254716
Sponsor's protocol ID
FudanU2024-01-17
Status last verified
Feb 2024
First submitted
17 Jan 2024
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Function and Quality of Life, run by Fudan University at 1 site in China.

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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hexia Xia, M.D. (+8613601843476, hexia_xia@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complication rate of surgery (time frame: one year after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Feb 2024.

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