Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study

Sawai Mansingh Medical College

Status: Completed

Conditions: Stoma Colostomy; Ileus; Anastomosis; Stoma Ileostomy; Bowel Obstruction; Leak, Anastomotic

Treatments: Procedure: Hand sewn side-to-side anastomosis; Procedure: Stapled side-to-side anastomosis; Procedure: Hand sewn end-to-end anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05753709

37/MC/EC/2021

Details and patient eligibility

About

The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is:

• If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity.

Participants admitted for stoma reversal will be divided into two groups:

1. EE: Conventional Hand-sewn end-to-end anastomosis, and

2. SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:

   1. HSSA: Hand-sewn side-to-side anastomosis
   2. SSSA: Stapled side-to-side anastomosis

Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see:

1. Rates of major post-operative complications
2. Rates of short-term complications (within 30 days of surgery)
3. Rates of re-operation
4. Post-operative length of stay in the hospital

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible participants were all the patients admitted in general surgical wards of SMS Hospital, Jaipur, for stoma reversal, after taking written informed consent

Exclusion criteria

• Pre-operatively diagnosed malnutrition or cachexia
• Bleeding disorders
• Patients undergoing stoma reversal along with a concurrent abdominal surgery
• Rectal anastomosis
• Use of circular stapler for anastomosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

38 participants in 3 patient groups

EE

Active Comparator group

Description:

End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures

Treatment:

Procedure: Hand sewn end-to-end anastomosis

SSSA

Active Comparator group

Description:

Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device

Treatment:

Procedure: Stapled side-to-side anastomosis

HSSA

Active Comparator group

Description:

Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation

Treatment:

Procedure: Hand sewn side-to-side anastomosis