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

Study Overview
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Brief Summary
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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: EE: Conventional Hand-sewn end-to-end anastomosis, and SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups: HSSA: Hand-sewn side-to-side anastomosis 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: Rates of major post-operative complications Rates of short-term complications (within 30 days of surgery) Rates of re-operation Post-operative length of stay in the hospital

Official Title
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Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Randomised Clinical Trial

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

Intervention / Treatment
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* Procedure: Hand sewn end-to-end anastomosis
* Procedure: Hand sewn side-to-side anastomosis
* Procedure: Stapled side-to-side anastomosis


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EE<br>End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures | Procedure: Hand sewn end-to-end anastomosis<br>* Hand sewn end-to-end anastomosis (EE) Holding sutures were taken through a seromuscular bite with PDS (Polydiaxonone) 3-0 or Silk 2-0 RB (Round Bodied needle), one each at the mesenteric and antimesenteric ends of the stoma. A posterior layer of Lembert sutures was taken first. The first bite was taken at the anti-mesenteric end and a knot was applied. A Connell stitch was applied at the corner and then the posterior layer was closed using an inverting interlocking continuous stitch till the mesenteric end. Another Connell stitch was applied here to secure the corner and the suture was continued on to the anterior layer which was then closed in a similar manner using a continuous interlocking stitch. The final bite crossed the initial knot and the final knot was applied. An anterior layer of Lembert sutures was taken to reinforce the anastomotic line.<br>|
| Active Comparator: SSSA<br>Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device | Procedure: Stapled side-to-side anastomosis<br>* Stapled side-to-side anastomosis or Functional End-to-end anastomosis (SSSA/FEEA) The two limbs of a Linear Cutter SR55 are placed into the proximal and distal bowel loops of the stoma, facing as far away from the mesenteric border as possible and then fired. If both lumens are of similar size, traction sutures are applied with Silk 2-0 RB at the anterior and posterior termination ends of the staple line. The two ends are pulled away from each other, and a Linear Cutter SR75 is applied just below the edge of the bowel and fired. However, in case of an ileo-colostomy, after the first linear cutter SR55 is fired, the two suture lines are approximated in such a way that they do not get apposed but rather lie adjacent to each other. The lumen is then clamped in SR75 which is then fired.<br>|
| Active Comparator: HSSA<br>Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation | Procedure: Hand sewn side-to-side anastomosis<br>* Hand sewn side-to-side anastomosis (HSSA) Each end of the stoma was closed using either a single layer of inverting interlocking continuous sutures with PDS 3-0 or Silk 2-0 RB, or a Linear Stapling device. The two closed stumps were then brought adjacent to each other in an anti-peristaltic arrangement. A posterior layer of Lembert sutures was applied using Silk 2-0 RB. The bowel wall was incised using electrocautery close to the suture line. The incision was lengthened up to a width of at least 5-6 cm. The posterior and anterior layer was now closed using the same technique as in HS using PDS 3-0. An anterior layer of Lembert sutures was applied. The mesenteric defect was then closed using a superficial interrupted layer of Silk 2-0 RB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Post-operative Ileus (POI) | 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 | From the day of surgery for 30 days | 
| Number of participants with Anastomotic Leak | 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. | From the day of surgery for 30 days | 
| Number of participants with complications of Clavien-Dindo grade higher than 2 | Number of participants with complications developing post-operatively of Clavien-Dindo grade higher than 2, suggestive of a severe complication. | From the day of surgery for 30 days | 
| Number of participants with Bowel Obstruction | 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 | From the day of surgery for 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating Time | Time during surgery from incision to skin closure | Intraoperatively | 
| Number of participants with Wound Infection | Number of participants with Infection of the incision site ranging from simple local purulent collection to overt infection requiring re-operation | From the day of surgery for 30 days | 
| Number of participants with Anastomotic Bleeding | Number of participants with Evidence of bleeding around the anastomotic site, confirmed by a complaint of melena, or radiological or endoscopic findings. | From the day of surgery for 30 days | 
| Number of participants with Anastomotic Stricture | 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). | From the day of surgery for 30 days | 
| Number of participants with Intra-abdominal Collection | 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. | From the day of surgery for 30 days | 
| Number of participants with Re-operation | Number of participants developing complications severe enough and not responding to medical management, that needed to be re-operated | From the day of surgery for 30 days | 
| Number of participants with Organ Dysfunction for each individual organ | 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. | From the day of surgery for 30 days | 
| Overall Morbidity | 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. | From the day of surgery for 30 days |