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.
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.
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.
Parallel
conventional laparoscopy group
Procedure/SurgeryUnderwent 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-rectoscopy
Procedure/SurgeryUnderwent localization, observation and resection of bowel lesions using intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). The surgery for bowel endometriosis was completed laparoscopically.
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: 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.
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.
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.
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.
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.
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