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| ID | Type | Description | Link |
|---|---|---|---|
| SHDC12025134 | Other Grant/Funding Number | Shanghai Shenkang Hospital Development Center |
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The goal of this prospective, multicenter, randomized controlled trial is to compare the clinical efficacy and safety of intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) versus conventional laparoscopy (CL) in patients with bowel endometriosis (BE) undergoing surgery. The primary objective is to assess differences in postoperative bowel function improvement at 6 months between the two groups.
The main questions it aims to answer are:
Is there a significant difference in postoperative bowel function (primary endpoint) at 6 months postoperatively between IDLnR and CL groups? Do the two groups differ in secondary outcomes, including efficacy indicators (LARS score/cure rate/improvement rate, CRADI-8, Wexner score, GIQLI, EHP-30, VAS pain reduction) and safety indicators (30-day severe complications, antibiotic use intensity, hospital stay >7 days)? Researchers will randomize BE surgical patients to IDLnR or CL groups, then compare the above primary and secondary endpoints to evaluate IDLnR's clinical value.
Participants will undergo either IDLnR or CL surgery for BE lesions, and be followed up to assess bowel function, quality of life, pain, and safety outcomes as specified.
This study will fill evidence gaps for IDLnR in BE surgery, support its standardized application, optimize BE treatment strategies, and aim for complete lesion resection, preserved intestinal function, and improved long-term patient quality of life.
1. Objective Primary Objective: To evaluate the improvement in bowel function at 6 months postoperatively between the double-scope group (Intra-operative Dual Laparoscopy and Neo-rectoscopy, IDLnR) and the conventional laparoscopy group (CL) in patients with intestinal endometriosis.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL group | Active Comparator | Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions. |
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| IDLnR group | Experimental | The experimental group receives the novel IDLnR technique. The procedure begins with conventional laparoscopic exploration, followed by intra-operative neo-rectoscopy to check for mucosal involvement and identify lesion locations. After dual visualization, precise resection of bowel lesions is performed laparoscopically. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional laparoscopy group | Procedure | Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically. |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery. | Improvement was defined as a change in LARS grade at 6 months postoperatively from severe LARS to mild LARS or no LARS, or from mild LARS to no LARS. The LARS score was obtained using the LARS questionnaire. The definitions of each LARS grade are as follows:
| baseline, and 6 months after bowel surgery |
| Measure | Description | Time Frame |
|---|---|---|
| LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively) | The LARS cure rate is defined as the proportion of patients whose LARS grade improves to the "No LARS" category (with a LARS score of 0-20) at 12 months postoperatively. Specifically, it refers to the percentage of patients who achieve normal bowel function, with no significant defecation-related distress and no impact on daily life or social activities, as evaluated by the LARS questionnaire at the 12-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
Gender Eligibility Description: Given the pathological characteristics of endometriosis, which arises from the ectopic growth of endometrial tissue and is closely associated with the female reproductive system, participation in this study is based on biological sex (individuals assigned female at birth, AFAB), which is a necessary premise for the occurrence of endometriosis. Therefore, eligibility to participate in the study (based on biological sex) is limited by gender identity to a certain extent. Eligible self-identified genders include all self-identified genders (e.g., cisgender women, transgender men, non-binary individuals), provided that the participants were assigned female at birth (AFAB) and have a confirmed diagnosis of bowel endometriosis. There is no exclusion of any self-identified gender as long as the core criterion of being assigned female at birth (the biological basis for endometriosis) is met.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofang Yi, MD | Contact | +86 21 33189900 | yix@fudan.edu.cn | |
| Kai-kai Chang, MD | Contact | +86 21 33189900 | +86 1522169387 | changkk@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofang Yi | Obstetrics & Gynecology Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Peace Maternity and Child Health Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2026 |
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Intervention group: Underwent localization, observation and resection of bowel lesions using intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). The surgery for bowel endometriosis was completed laparoscopically.
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Due to the nature of surgical intervention, blinding of surgeons and patients was not feasible. However, outcome assessors and data analysts remained blinded to group allocation.
| intra-operative Dual Laparoscopy and Neo-rectoscopy | Procedure | Underwent localization, observation and resection of bowel lesions using intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). The surgery for bowel endometriosis was completed laparoscopically. |
|
| baseline, and 12 months postoperatively |
| LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively) | The LARS improvement rate is defined as the proportion of patients who experience a decrease in LARS grade at 3 and 12 months postoperatively. Specifically, it refers to patients whose LARS grade is reduced from their preoperative grade (e.g., from Major LARS to Minor LARS, from Major LARS to No LARS, or from Minor LARS to No LARS) as evaluated by the LARS questionnaire at the 3-month and 12-month postoperative follow-ups. | baseline, 3 and 12 months postoperatively |
| Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively) | The change in LARS score is defined as the difference in LARS scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 3, 6, and 12 months postoperatively. Specifically, it refers to the numerical change in LARS scores obtained from the LARS questionnaire, reflecting the degree of change in bowel function-related symptoms from the patient's preoperative state to each follow-up time point (3, 6, and 12 months after surgery). Minimum score: 0 Maximum score: 42 Interpretation: Higher scores indicate worse intestinal and defecatory function; lower scores indicate better function. | baseline, 3, 6, and 12 months postoperatively |
| Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively) | The change in Colorectal Anal Distress Inventory-8 (CRADI-8) score is defined as the difference in CRADI-8 scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 months postoperatively. Specifically, it refers to the numerical change in CRADI-8 scores obtained from the CRADI-8 questionnaire, reflecting the degree of change in colorectal and anal distress symptoms from the patient's preoperative state to the 6-month postoperative follow-up. Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate more severe colorectal-anal distress symptoms; lower scores indicate milder symptoms. | baseline, and 6 months postoperatively |
| Change in Wexner constipation score (change from baseline at 12 months postoperatively) | The change in Wexner constipation score is defined as the difference in Wexner constipation scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 12 months postoperatively. Specifically, it refers to the numerical change in Wexner constipation scores obtained from the relevant assessment tool, reflecting the degree of change in constipation-related symptoms from the patient's preoperative state to the 12-month postoperative follow-up. Minimum score: 0 Maximum score: 30 Interpretation: Higher scores indicate more severe constipation symptoms; lower scores indicate milder constipation. | baseline, 12 months postoperatively |
| Change in Gastrointestinal Quality of Life Index (GIQLI) score (changes from baseline at 6 and 12 months postoperatively). | The change in Gastrointestinal Quality of Life Index (GIQLI) score is defined as the difference in GIQLI scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 and 12 months postoperatively. Specifically, it refers to the numerical change in GIQLI scores obtained from the GIQLI questionnaire, reflecting the degree of change in gastrointestinal-related quality of life from the patient's preoperative state to the 6-month and 12-month postoperative follow-ups. Minimum score: 0 Maximum score: 144 Interpretation: Higher scores indicate better gastrointestinal quality of life; lower scores indicate poorer quality of life. | baseline, 6 and 12 months postoperatively |
| Change in Endometriosis Health Profile-30 (EHP-30) score (changes from baseline at 6 and 12 months postoperatively) | The change in Endometriosis Health Profile-30 (EHP-30) score is defined as the difference in EHP-30 scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 and 12 months postoperatively. Specifically, it refers to the numerical change in EHP-30 scores obtained from the EHP-30 questionnaire, reflecting the degree of change in endometriosis-related health status from the patient's preoperative state to the 6-month and 12-month postoperative follow-ups. Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate worse symptoms and poorer health-related quality of life; lower scores indicate better health status. | baseline, 6 and 12 months postoperatively |
| Proportion of patients with ≥ 50% reduction in Visual Analogue Scale (VAS) score at 6 months postoperatively compared with baseline. | The proportion of patients with a ≥ 50% reduction in Visual Analogue Scale (VAS) score at 6 months postoperatively compared with baseline is defined as the percentage of patients whose VAS score decreases by 50% or more at the 6-month postoperative follow-up relative to their preoperative (baseline) VAS score. It reflects the proportion of patients with significant improvement in pain-related symptoms. Minimum score: 0 Maximum score: 10 Interpretation: Higher scores indicate more severe pain; lower scores indicate milder or no pain. | baseline, and 6 months postoperatively |
| Incidence of severe complications within 30 days postoperatively | The incidence of severe complications within 30 days postoperatively refers to the proportion of patients who experience severe complications within 30 days after surgery. These severe complications include intestinal perforation, intestinal anastomotic leakage/fistula, and intestinal bleeding, which are defined as events with a Clavien-Dindo classification of ≥ Grade III. Specifically, it refers to the percentage of patients who develop any of the aforementioned severe complications within 30 days after surgery, where the complications meet the criteria of Clavien-Dindo classification ≥ Grade III. | within 30 days postoperatively |
| Antibiotic Use Intensity within 7 days postoperatively | Definition and scope: Only therapeutic antibiotics initiated or continued postoperatively due to fever are included. The study period is defined as postoperative days 0-7. Calculation of therapeutic antibiotic DDDs: Total DDDs = Σ (Total consumption of each antibiotic in g / WHO-DDD value of that antibiotic in g). Total consumption of each antibiotic (g) = Single dose (g) × Times per day × Duration of therapy (days). | 0-7 days postoperatively |
| Proportion of patients with postoperative hospital stay > 7 days | The proportion of patients with postoperative hospital stay > 7 days is defined as the percentage of patients whose length of hospital stay after surgery exceeds 7 days. Specifically, it refers to the proportion of participants whose total hospital stay from the time of surgery to discharge is longer than 7 days, reflecting the proportion of patients with prolonged postoperative hospitalization. | 30 days postoperatively |
| Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201101 | China |
| Shanghai First Maternity and Infant Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 201101 | China |
|
| May 8, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form | Feb 28, 2026 | May 8, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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