"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

NCT06010043 | Completed

• 1 other identifier: XHEC-2023-D-146
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy; Complications

Keywords

ileostomy; complications; NOSES; stoma suture

Outcome Measures

Primary Outcomes (1)

• Complication rate of stoma

  Observe and assess for stoma complications

  Day 30 after surgery

Secondary Outcomes (3)

• Stoma DET（Discoloration，Erosion and Tissue overgrowth） score

  Day 30 after surgery

• Stoma Pain Score

  Day 30 after surgery

• Quality of life scale score for patients with stoma

  Day 30 after surgery

Study Arms (2)

"Dumpling suture" for ileostomy

EXPERIMENTAL

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"

Traditional suture for ileostomy

OTHER

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

Interventions

Suturing of ileostomy using "Dumpling suture method" PROCEDURE

Suturing of ileostomy using "Dumpling suture method"

"Dumpling suture" for ileostomy

Suturing of ileostomy using Traditional suture method PROCEDURE

Suturing of ileostomy using Traditional suture method

Traditional suture for ileostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: August 1, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 15, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)