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.
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
- Conditions the study is for
- Gastrointestinal Function, Quality of Life, Pregnancy Outcomes
- 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
- Recruiting
OB & GYN Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
Hexia Xia, M.D., +8613601843476
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
- 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.
- 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.
- 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.
- Key research methods and technologies:
Research methods: Single-center retrospective study
- 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.
- 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.
- 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.).
- 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).
- 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).
- Follow-up method: Obtain preliminary results through outpatient electronic medical records; telephone follow-up for patient symptom assessment.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: segmental resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate of surgery
rate of rectovaginal fistula or anastomotic fistula
Measured: one year after surgery
gastrointestinal function
The scoring of lower anterior resection syndrome (lower anterior resection syndrome
Measured: one year after surgery
recurrence rate
Recurrence rate of symptoms or image findings
Measured: one year after surgery
Secondary outcomes (2)
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
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.
- First posted12 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal FunctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wei, Fudan University
- Investigators
- Wei Zhang, Ph.D., Study director, OB & GYN Hospital of Fudan University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06254716
- Acronym / sponsor ID
- FudanU2024-01-17
- Keywords
- rectal endometriosis, disc resection, segmental resection, anastomose, gastrointestinal function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- Key research methods and technologies:
Research methods: Single-center retrospective study
- 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.
- 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.
- 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.).
- 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).
- 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).
- Follow-up method: Obtain preliminary results through outpatient electronic medical records; telephone follow-up for patient symptom assessment.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disc resection of rectal endometriosis | – | Procedure: disc resectionPatients 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. |
| Segmental resection of rectal endometriosis | – | Procedure: segmental resectionPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disc resectiondisc 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. | Procedure or surgery | Disc resection of rectal endometriosis |
| segmental resectionSegmental 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. | Procedure or surgery | Segmental resection of rectal endometriosis |
Primary outcome
complication rate of surgery
Time frame: one year after surgery
rate of rectovaginal fistula or anastomotic fistula
gastrointestinal function
Time frame: one year after surgery
The scoring of lower anterior resection syndrome (lower anterior resection syndrome
recurrence rate
Time frame: one year after surgery
Recurrence rate of symptoms or image findings
2 secondary outcomes
gastrointestinal function- related quality of life index
Time frame: one year after surgery
pregnancy outcome
Time frame: one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongmin Wang, M.M. contact
Wei Zhang, Ph.D. study director
OB & GYN Hospital of Fudan University
1 site in 1 country: see every site and its status.
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.