Clinical trial NCT06010043: "Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study
Official title: "Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy; Complications
Keywords: ileostomy
complications
NOSES
stoma suture
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics. Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to divert feces and protect the anastomosis. For such patients, rectal anterior resection surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also realizing the absence of additional abdominal incision. However, this procedure is prone to stoma infection and has a high complication rate (20-40%), which limits the popularization of NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure method (Dumpling Suture Method), which reduces the size of the incision by folding the suture to achieve the effect of hiding the skin incision and reduce stoma infection. The study aimed to introduce the "Dumpling suture method" of protective loop ileostomy in laparoscopic anterior resection and compare this new method with the traditional method. From August 1st 2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30 patients with stoma closure by the traditional method were included in the same period for control purposes. A retrospective analysis was conducted on 52 patients in the study center, and the intraoperative details and postoperative outcomes of the two groups were measured.


Eligibility criteria: Inclusion Criteria:

1. All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision;
2. All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis;
3. Patients aged 18 - 80 years
4. ASA (American Society of Anesthesiologists) classification ≤ grade 3.
5. Patient participate voluntarily and sign an informed consent form

Exclusion Criteria:

1. Patients with distant metastasis;
2. Patients with colon cancer;
3. Patients with a history of previous abdominal surgery;
4. ASA (American Society of Anesthesiologists) classification \> grade 3;
5. Patients who underwent emergency surgery;
6. Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ;
7. Patients lost to follow-up.

Primary outcomes:
measure: Complication rate of stoma
timeFrame: Day 30 after surgery
Secondary outcomes:
measure: Stoma DET（Discoloration，Erosion and Tissue overgrowth） score
timeFrame: Day 30 after surgery
measure: Stoma Pain Score
timeFrame: Day 30 after surgery
measure: Quality of life scale score for patients with stoma
timeFrame: Day 30 after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: