Bowel EndometriosisLUMEN-01NCT07523308
Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy for Bowel Endometriosis: The LUMEN-01 Trial
A study testing conventional laparoscopy group and intra-operative Dual Laparoscopy and Neo-rectoscopy in people with Bowel Endometriosis and Endometriosis, run by Obstetrics & Gynecology Hospital of Fudan University at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Bowel Endometriosis, Endometriosis, Intestinal Endometriosis
- What is being tested?
- conventional laparoscopy group and intra-operative Dual Laparoscopy and Neo-rectoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 3 sitesChina
- Study dates
- 13 Apr 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women aged 18 to 55 years.
- Preoperative pelvic contrast-enhanced MRI and/or transrectal endosonography confirmed bowel endometriosis (BE) lesions involving the muscular layer of the intestinal wall, located in the rectum and/or sigmoid colon. Postoperative pathological diagnosis serves as the gold standard.
- Pre-treatment LARS score > 20.
- Eligible for laparoscopic surgery.
- Voluntarily participated in this study and signed written informed consent
Who cannot join
- Pregnancy or lactation.
- Presence of active inflammatory bowel disease, irritable bowel syndrome, or other similar conditions with disease flare-ups within the past 1 year.
- Acute or severe infectious disease within 4 weeks prior to surgery.
- History of malignant tumor, or highly suspected gynecological/gastrointestinal malignancy based on preoperative imaging or tumor marker tests.
- American Society of Anesthesiologists (ASA) physical status classification ≥ Grade Ⅲ, or severe cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that precludes general anesthesia and elective laparoscopic surgery.
- Undergoing robot-assisted laparoscopic surgery or open laparotomy.
Show all 10Show fewer
- Currently participating in other clinical trials that may affect the outcome assessment of this study.
- Previous participation in other interventional clinical trials that may affect the outcome assessment of this study.
- History of colorectal resection and anastomosis or stoma surgery.
- History of pelvic radiotherapy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030
Feng Sun, MD, +86 13585621594, sunfeng0711@126.com
Jing Ouyang, MD, ouyangjing126@126.com
- Recruiting
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 201101
- Not yet recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201101
Shuangdi Li, MD, +86 15921664530, lishuangdi21@126.com
Yu Li, Master, +86 18049920519, liyu19831221@126.com
About this study
Official title: Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR) Versus Conventional Laparoscopic Surgery for Bowel Endometriosis: A Multicenter, Open-Label, Randomized Controlled Trial (LUMEN-01)
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:
Read more
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.
Read the detailed description
- 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:
- To evaluate the incidence of complications and severe complications within 30 days postoperatively in both groups, including anastomotic leakage, intestinal injury, intestinal bleeding, etc.
- To evaluate changes in postoperative pain relief, gastrointestinal function, and quality of life between the two groups.
- Conditions
- Bowel Endometriosis, Endometriosis, Intestinal Endometriosis
- Being tested
- conventional laparoscopy group, intra-operative Dual Laparoscopy and Neo-rectoscopy
- Keywords
- Bowel Endometriosis, Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR), Efficacy, Safety, LARS
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional laparoscopy groupProcedure or surgery
Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.
intra-operative Dual Laparoscopy and Neo-rectoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CL group | Active comparator | Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions. Receives: Procedure: conventional laparoscopy group |
| 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. Receives: Procedure: intra-operative Dual Laparoscopy and Neo-rectoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- No LARS: score 0-20; normal bowel function with no significant defecation-related distress and no impact on daily life or social activities.
- Minor LARS: score 21-29; presence of symptoms such as flatus or fecal incontinence, increased stool frequency, or urgency, but mild in severity. These symptoms are largely controllable through dietary modification and bowel habit adjustment, with limited impact on quality of life.
- Major LARS: score 30-42; severe symptoms including frequent fecal incontinence, intractable severe urgency, and cluster defecation, which significantly interfere with daily activities, social life, and psychological status.
Measured: baseline, and 6 months after bowel surgery
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start13 Apr 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel EndometriosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Study Design: a multicenter, open-label, parallel-group randomized controlled trial (RCT) conducted by three tertiary medical centers. Eligible patients will be randomly assigned in a 1:1 ratio to receive either the double-scope group (Intra-operative Dual Laparoscopy and Neo-rectoscopy, IDLnR) technique or conventional laparoscopy (CL). The primary endpoint is the rate of improvement in the Low Anterior Resection Syndrome (LARS) score category at 6 months after intestinal surgery. 2. Case Grouping Control group: Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically. 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofang Yi, Obstetrics & Gynecology Hospital of Fudan University
- Investigators
- Xiaofang Yi, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523308
- Sponsor's protocol ID
- OBGynFudanU-2026-LUMEN 01
- Other IDs
- SHDC12025134
- Acronym
- LUMEN-01
- Status last verified
- May 2026
- First submitted
- 4 Apr 2026
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR) Versus Conventional Laparoscopic Surgery for Bowel Endometriosis: A Multicenter, Open-Label, Randomized Controlled Trial (LUMEN-01)
- ClinicalTrials.gov ID
- NCT07523308
- Acronym / sponsor ID
- LUMEN-01 / OBGynFudanU-2026-LUMEN 01
- Conditions
- Bowel Endometriosis, Endometriosis, Intestinal Endometriosis
- Keywords
- Bowel Endometriosis, Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR), Efficacy, Safety, LARS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
Detailed description
- 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:
- To evaluate the incidence of complications and severe complications within 30 days postoperatively in both groups, including anastomotic leakage, intestinal injury, intestinal bleeding, etc.
- To evaluate changes in postoperative pain relief, gastrointestinal function, and quality of life between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Study Design: a multicenter, open-label, parallel-group randomized controlled trial (RCT) conducted by three tertiary medical centers. Eligible patients will be randomly assigned in a 1:1 ratio to receive either the double-scope group (Intra-operative Dual Laparoscopy and Neo-rectoscopy, IDLnR) technique or conventional laparoscopy (CL). The primary endpoint is the rate of improvement in the Low Anterior Resection Syndrome (LARS) score category at 6 months after intestinal surgery. 2. Case Grouping Control group: Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically. 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.
| Arm | Type | Receives |
|---|---|---|
| CL group | Active comparator | Procedure: conventional laparoscopy groupParticipants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions. |
| IDLnR group | Experimental | Procedure: intra-operative Dual Laparoscopy and Neo-rectoscopyThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal women aged 18 to 55 years.
- Preoperative pelvic contrast-enhanced MRI and/or transrectal endosonography confirmed bowel endometriosis (BE) lesions involving the muscular layer of the intestinal wall, located in the rectum and/or sigmoid colon. Postoperative pathological diagnosis serves as the gold standard.
- Pre-treatment LARS score > 20.
- Eligible for laparoscopic surgery.
- Voluntarily participated in this study and signed written informed consent
Key exclusion criteria (10 listed)
- Pregnancy or lactation.
- Presence of active inflammatory bowel disease, irritable bowel syndrome, or other similar conditions with disease flare-ups within the past 1 year.
- Acute or severe infectious disease within 4 weeks prior to surgery.
- History of malignant tumor, or highly suspected gynecological/gastrointestinal malignancy based on preoperative imaging or tumor marker tests.
- American Society of Anesthesiologists (ASA) physical status classification ≥ Grade Ⅲ, or severe cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that precludes general anesthesia and elective laparoscopic surgery.
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 |
|---|---|---|
| conventional laparoscopy groupUnderwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically. | Procedure or surgery | CL group |
| intra-operative Dual Laparoscopy and Neo-rectoscopyUnderwent localization, observation and resection of bowel lesions using intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). The surgery for bowel endometriosis was completed laparoscopically. | Procedure or surgery | IDLnR group |
Primary outcome
The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery.
Time frame: baseline, and 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: 1. No LARS: score 0-20; normal bowel function with no significant defecation-related distress and no impact on daily life or social activities. 2. Minor LARS: score 21-29; presence of symptoms such as flatus or fecal incontinence, increased stool frequency, or urgency, but mild in severity. These symptoms are largely controllable through dietary modification and bowel habit adjustment, with limited impact on quality of life. 3. Major LARS: score 30-42; severe symptoms including frequent fecal incontinence, intractable severe urgency, and cluster defecation, which significantly interfere with daily activities, social life, and psychological status.
11 secondary outcomes
LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively)
Time frame: baseline, and 12 months postoperatively
LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively)
Time frame: baseline, 3 and 12 months postoperatively
Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively)
Time frame: baseline, 3, 6, and 12 months postoperatively
Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively)
Time frame: baseline, and 6 months postoperatively
Change in Wexner constipation score (change from baseline at 12 months postoperatively)
Time frame: baseline, 12 months postoperatively
Change in Gastrointestinal Quality of Life Index (GIQLI) score (changes from baseline at 6 and 12 months postoperatively).
Time frame: baseline, 6 and 12 months postoperatively
Change in Endometriosis Health Profile-30 (EHP-30) score (changes from baseline at 6 and 12 months postoperatively)
Time frame: 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.
Time frame: baseline, and 6 months postoperatively
Incidence of severe complications within 30 days postoperatively
Time frame: within 30 days postoperatively
Antibiotic Use Intensity within 7 days postoperatively
Time frame: 0-7 days postoperatively
Proportion of patients with postoperative hospital stay > 7 days
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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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.
Xiaofang Yi principal investigator
Obstetrics & Gynecology Hospital of Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional laparoscopy group and intra-operative Dual Laparoscopy and Neo-rectoscopy in people with Bowel Endometriosis and Endometriosis, run by Obstetrics & Gynecology Hospital of Fudan University at 3 sites 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofang Yi, MD (+86 21 33189900, yix@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery. (time frame: baseline, and 6 months after bowel surgery). 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 19 May 2026.