Clinical trial NCT05753709: Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study
Official title: Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Stoma Colostomy
Anastomosis
Ileus
Leak, Anastomotic
Bowel Obstruction
Lead sponsor: Sawai Mansingh Medical College
Sponsor class: OTHER_GOV
First posted: 2023-03-03
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups in parallel: EE and SS, and another comparison with three arms: EE versus SS divided into two separate arms: SSSA and HSSA
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Post-operative Ileus (POI)
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Anastomotic Leak
timeFrame: From the day of surgery for 30 days
measure: Number of participants with complications of Clavien-Dindo grade higher than 2
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Bowel Obstruction
timeFrame: From the day of surgery for 30 days
Secondary outcomes:
measure: Operating Time
timeFrame: Intraoperatively
measure: Number of participants with Wound Infection
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Anastomotic Bleeding
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Anastomotic Stricture
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Intra-abdominal Collection
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Re-operation
timeFrame: From the day of surgery for 30 days
measure: Number of participants with Organ Dysfunction for each individual organ
timeFrame: From the day of surgery for 30 days
measure: Overall Morbidity
timeFrame: From the day of surgery for 30 days
Other outcomes:
measure: Days to Bowel Movement
timeFrame: From the day of surgery for 30 days
measure: Days to Liquid diet
timeFrame: From the day of surgery for 30 days
measure: Days to Solid diet
timeFrame: From the day of surgery for 30 days
measure: Postoperative length of stay
timeFrame: From the day of surgery for 30 days
Locations:
city: Jaipur
country: India
facility: Sawai Mansingh Medical College and Hospital
state: Rajasthan
Study officials:
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