Effektivitet og sikkerhed af intraoperativ dual laparoskopi og neo-rektoskopi vs konventionel laparoskopi for tarmendometriose: LUMEN-01-forsøget (LUMEN-01)

Aktiv komparator: CL-gruppe

Deltagerne i denne gruppe vil gennemgå standard laparoskopisk kirurgi til lokalisering, observation og resektion af endometriose-læsioner i tarmen.

Procedure: konventionel laparoskopigruppe

Under gik lokaliserings-, observations- og resektion af tarmlæsioner ved hjælp af konventionel laparoskopi (CL). Kirurgien for tarmendometriose blev fuldført laparoskopisk.

Eksperimentel: IDLnR-gruppen

Den eksperimentelle gruppe modtager den nye IDLnR-teknik.
Proceduren begynder med konventionel laparoskopisk udforskning, efterfulgt af intraoperativ neo-rektoskopi for at kontrollere for slimhindeinddragelse og identificere læsionsplaceringer.
Efter dobbeltvisualisering udføres præcis resektion af tarmlæsioner laparoskopisk.

Procedure: intraoperativ Dual Laparoskopi og Nylig Rektoskopi

Under lokaliserings-, observations- og resektionsprocedure for tarmlæsioner ved brug af intraoperativ Dual Laparoskopi og Neo-rektoskopi (IDLnR). Kirurgien for tarmendometriose blev afsluttet laparoskopisk.

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 helbredelsesrate (LARS-grad forbedret til ingen LARS 12 måneder postoperativt)

LARS helbredelsesprocenten defineres som andelen af patienter, hvis LARS-grad forbedres til kategorien "Ingen LARS" (med en LARS-score på 0-20) 12 måneder efter operationen. Specifikt refererer det til procentdelen af patienter, der opnår normal tarmsfunktion, uden væsentlig afføringsrelateret ubehag og ingen indvirkning på dagligdagen eller sociale aktiviteter, som vurderet af LARS-spørgeskemaet ved 12-måneders opfølgningen.

LARS-forbedringshastighed (reduktion i LARS-grad 3 og 12 måneder postoperativt)

LARS-forbedringshastigheden er defineret som andelen af patienter, der oplever et fald i LARS-graden 3 og 12 måneder postoperativt. Specifikt refererer det til patienter, hvis LARS-grad er reduceret fra deres præoperative grad (f.eks. fra Major LARS til Minor LARS, fra Major LARS til Ingen LARS, eller fra Minor LARS til Ingen LARS) som vurderet ved LARS-spørgeskemaet ved de 3-måneders og 12-måneders postoperative opfølgninger.

Forekomst af alvorlige komplikationer inden for 30 dage postoperativt

Forekomsten af alvorlige komplikationer inden for 30 dage postoperativt refererer til andelen af patienter, der oplever alvorlige komplikationer inden for 30 dage efter operationen. Disse alvorlige komplikationer inkluderer tarmperforation, tarmanastomose-lækage/fistel og tarmblødning, som defineres som hændelser med en Clavien-Dindo-klassifikation på ≥ grad III. Specifikt refererer det til procentdelen af patienter, der udvikler en hvilken som helst af de ovennævnte alvorlige komplikationer inden for 30 dage efter operationen, hvor komplikationerne opfylder kriterierne for Clavien-Dindo-klassifikation ≥ grad III.

Intensitet af antibiotikaforbrug inden for 7 dage postoperativt

Definition og omfang: Kun terapeutiske antibiotika, der påbegyndes eller fortsættes postoperativt på grund af feber, er inkluderet. Studieperioden er defineret som postoperative dag 0-7.

Beregning af terapeutiske antibiotika DDD'er:

Total DDD'er = Σ (Samlet forbrug af hvert antibiotikum i g / WHO-DDD-værdi for det pågældende antibiotikum i g).

Samlet forbrug af hvert antibiotikum (g) = Enkeltdosis (g) × Gange om dagen × Behandlingsvarighed (dage).

Andel af patienter med postoperativ hospitalsindlæggelse > 7 dage

Andelen af patienter med et postoperativt hospitalsophold > 7 dage defineres som procentdelen af patienter, hvis længde af hospitalsopholdet efter operationen overstiger 7 dage. Specifikt henviser det til andelen af deltagere, hvis samlede hospitalsophold fra tidspunktet for operationen til udskrivelsen er længere end 7 dage, hvilket afspejler andelen af patienter med forlænget postoperativ hospitalsindlæggelse.

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.