术中双腹腔镜联合新直肠镜与传统腹腔镜治疗肠道子宫内膜异位症的疗效与安全性：LUMEN-01试验 (LUMEN-01)

有源比较器：CL组

该组参与者将接受标准腹腔镜手术，以定位、观察和切除肠道子宫内膜异位病灶。

程序：常规腹腔镜组

使用传统腹腔镜（CL）进行肠道病灶的定位、观察和切除。 肠道子宫内膜异位症的手术通过腹腔镜方式完成。

实验性的：IDLnR 组

实验组接受新型IDLnR技术治疗。 手术从常规腹腔镜探查开始，随后进行术中新生直肠镜检查，以确认黏膜是否受累并定位病灶位置。 在双重可视化引导下，通过腹腔镜对肠道病灶进行精准切除。

程序：术中双腹腔镜与新生直肠镜检查

术中采用双腹腔镜与新型直肠镜（IDLnR）对肠病灶进行定位、观察和切除。 肠子宫内膜异位症手术以腹腔镜方式完成。

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治愈率（术后12个月时LARS分级改善至无LARS）

LARS 治愈率定义为术后 12 个月时 LARS 等级改善至“无 LARS”类别（LARS 评分为 0-20 分）的患者比例。 具体而言，它指的是在 12 个月随访时，通过 LARS 问卷评估，达到正常肠道功能、无明显排便相关困扰且对日常生活或社交活动无影响的患者百分比。

LARS改善率（术后3个月和12个月LARS等级降低）

LARS改善率定义为术后3个月和12个月时LARS等级降低的患者比例。 具体而言，指在术后3个月和12个月的随访中，通过LARS问卷评估，其LARS等级较术前等级降低的患者（例如，从重度LARS降至轻度LARS、从重度LARS降至无LARS，或从轻度LARS降至无LARS）。

术后30天内严重并发症的发生率

术后30天内严重并发症发生率是指术后30天内出现严重并发症的患者比例。 这些严重并发症包括肠穿孔、肠吻合口漏/瘘和肠出血，定义为Clavien-Dindo分级≥Ⅲ级的事件。 具体而言，它是指术后30天内出现上述任何一种严重并发症的患者百分比，其中并发症符合Clavien-Dindo分级≥Ⅲ级的标准。

术后7天内抗生素使用强度

定义与范围：仅包含因术后发热而开始或继续使用的治疗性抗生素。 研究周期定义为术后第0-7天。

治疗性抗生素DDDs计算：

总DDDs = Σ（每种抗生素总消耗量（g）/该抗生素的WHO-DDD值（g））。

每种抗生素总消耗量（g）= 单次剂量（g）×每日使用次数×治疗持续时间（天）。

术后住院时间 > 7 天的患者比例

术后住院时间 > 7 天的患者比例定义为手术后住院时间超过 7 天的患者百分比。 具体而言，它指的是从手术时间到出院的总住院时间长于 7 天的参与者比例，反映了术后住院时间延长患者的比例。

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.

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.

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.

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.

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.