Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study
- Conditions
- Stoma ColostomyAnastomosisBowel ObstructionStoma IleostomyIleusLeak, Anastomotic
- Interventions
- Procedure: Hand sewn side-to-side anastomosisProcedure: Hand sewn end-to-end anastomosisProcedure: Stapled side-to-side anastomosis
- Registration Number
- NCT05753709
- Lead Sponsor
- Sawai Mansingh Medical College
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Eligible participants were all the patients admitted in general surgical wards of SMS Hospital, Jaipur, for stoma reversal, after taking written informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HSSA Hand sewn side-to-side anastomosis Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation EE Hand sewn end-to-end anastomosis End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures SSSA Stapled side-to-side anastomosis Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device
- Primary Outcome Measures
Name Time Method Number of participants with Post-operative Ileus (POI) From the day of surgery for 30 days Number of participants with two or more episodes of nausea/vomiting, inability to tolerate oral diet over 24 hours, absence of flatus over 24 hours, or distension, and with radiologic confirmation, occurring postoperatively without spontaneous resolution
Number of participants with Anastomotic Leak From the day of surgery for 30 days Number of participants with leakage of bowel contents from the anastomotic site, confirmed with imaging studies and clinical signs, such as fever \>38.5˚C, leucocytosis, elevated serum C-reactive protein, drainage of intestinal content from the drain or computed tomography findings of abscess formation around the anastomosis.
Number of participants with complications of Clavien-Dindo grade higher than 2 From the day of surgery for 30 days Number of participants with complications developing post-operatively of Clavien-Dindo grade higher than 2, suggestive of a severe complication.
Number of participants with Bowel Obstruction From the day of surgery for 30 days Number of participants with Bowel dilatation and obstipation (inability to pass flatus as well as motion), requiring surgery for treatment, with transition point of the obstruction confirmed either radiologically or intraoperatively
- Secondary Outcome Measures
Name Time Method Operating Time Intraoperatively Time during surgery from incision to skin closure
Number of participants with Wound Infection From the day of surgery for 30 days Number of participants with Infection of the incision site ranging from simple local purulent collection to overt infection requiring re-operation
Number of participants with Anastomotic Stricture From the day of surgery for 30 days Number of participants with Imaging studies done in patients with complaints of nausea or bloating after oral intake, demonstrating intestinal distension starting from oral side of the anastomotic site, occurring due to narrowing at the site of anastomosis due to any cause. This did not include patients unable to pass flatus and motion (obstipation, criteria for bowel obstruction) or patients only unable to tolerate oral diet without other symptoms (criteria for POI).
Overall Morbidity From the day of surgery for 30 days The overall morbidity is reflective of the number of patients who have at least 1 complication; that is, patients who have at least 1 complication were counted only once, and only their highest-grade complication was counted, graded on the Clavien-Dindo scale.
Number of participants with Intra-abdominal Collection From the day of surgery for 30 days Number of participants with fluid collection inside the abdominal cavity developing post-operatively, of any origin, which was not present before surgery. The fluid collection includes presence of ascitic fluid, blood or pus, in amount sufficient to be detected by an abdominal ultrasound or computed tomography imaging. The number of participants showing presence of fluid was measured, and not the volume of fluid.
Number of participants with Anastomotic Bleeding From the day of surgery for 30 days Number of participants with Evidence of bleeding around the anastomotic site, confirmed by a complaint of melena, or radiological or endoscopic findings.
Number of participants with Re-operation From the day of surgery for 30 days Number of participants developing complications severe enough and not responding to medical management, that needed to be re-operated
Number of participants with Organ Dysfunction for each individual organ From the day of surgery for 30 days Number of participants with Dysfunction in any organ, evidenced by symptoms and blood tests, developing post-operatively and not present before surgery. The outcome was measured as the number of participants developing dysfunction of each a particular organ system, labelled as Renal, Cardiac, Hepatic, Vascular and Respiratory.
Trial Locations
- Locations (1)
Sawai Mansingh Medical College and Hospital
🇮🇳Jaipur, Rajasthan, India