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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ileostomy; Complications

Intervention / Treatment
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* Procedure: Suturing of ileostomy using Dumpling suture method
* Procedure: Suturing of ileostomy using Traditional suture method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients underwent successful laparoscopic anterior rectal resection plus protective loop ileostomy with specimen extraction through stoma incision; All patients were pathologically diagnosed with rectal carcinoma or ulcerative colitis; Patients aged 18 - 80 years ASA (American Society of Anesthesiologists) classification ≤ grade 3. Patient participate voluntarily and sign an informed consent form Exclusion Criteria: Patients with distant metastasis; Patients with colon cancer; Patients with a history of previous abdominal surgery; ASA (American Society of Anesthesiologists) classification > grade 3; Patients who underwent emergency surgery; Patients who underwent surgery ≤ 3 weeks from the last chemotherapy ; Patients lost to follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dumpling suture for ileostomy<br>The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision. | Procedure: Suturing of ileostomy using Dumpling suture method<br>* Suturing of ileostomy using Dumpling suture method<br>|
| Other: Traditional suture for ileostomy<br>The stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures. | Procedure: Suturing of ileostomy using Traditional suture method<br>* Suturing of ileostomy using Traditional suture method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate of stoma | Observe and assess for stoma complications | Day 30 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoma DET（Discoloration，Erosion and Tissue overgrowth） score | Measure the state of the skin around the stoma and the corresponding lesion area, ranging from 0-15, higher scores mean a worse outcome of stoma | Day 30 after surgery | 
| Stoma Pain Score | Measurement of stoma pain level using numerical rating scale，ranging from 0-10, higher scores mean a worse outcome of pain | Day 30 after surgery | 
| Quality of life scale score for patients with stoma | Measurement of quality of life for patients with stoma using City of Hope Quality of Life-Ostomy Questionnaire (CHO-QOL-OQ), ranging from 0-3200, higher scores mean a worse outcome of quality of life | Day 30 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, NOSES, stoma suture, ileostomy