"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

Ileostomy; Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06010043
• Other study ID #: XHEC-2023-D-146
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 15, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ileostomy; Complications

Intervention

Procedure:
• Suturing of ileostomy using "Dumpling suture method"
Suturing of ileostomy using "Dumpling suture method"
• Suturing of ileostomy using Traditional suture method
Suturing of ileostomy using Traditional suture method

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate of stoma	Observe and assess for stoma complications	Day 30 after surgery
Secondary	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
Secondary	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
Secondary	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