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

February 22, 2023 updated by: Tanmay Agarwal, Sawai Mansingh Medical College

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Sawai Mansingh Medical College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EE
End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures
Procedure: Hand sewn end-to-end anastomosis
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.
Active Comparator: SSSA
Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device
Procedure: Stapled side-to-side anastomosis
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.
Active Comparator: HSSA
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Post-operative Ileus (POI)
Time Frame: 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
From the day of surgery for 30 days
Number of participants with Anastomotic Leak
Time Frame: 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.
From the day of surgery for 30 days
Number of participants with complications of Clavien-Dindo grade higher than 2
Time Frame: 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.
From the day of surgery for 30 days
Number of participants with Bowel Obstruction
Time Frame: 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
From the day of surgery for 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating Time
Time Frame: Intraoperatively
Time during surgery from incision to skin closure
Intraoperatively
Number of participants with Wound Infection
Time Frame: 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
From the day of surgery for 30 days
Number of participants with Anastomotic Bleeding
Time Frame: 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.
From the day of surgery for 30 days
Number of participants with Anastomotic Stricture
Time Frame: 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).
From the day of surgery for 30 days
Number of participants with Intra-abdominal Collection
Time Frame: 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.
From the day of surgery for 30 days
Number of participants with Re-operation
Time Frame: 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
From the day of surgery for 30 days
Number of participants with Organ Dysfunction for each individual organ
Time Frame: 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.
From the day of surgery for 30 days
Overall Morbidity
Time Frame: 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.
From the day of surgery for 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days to Bowel Movement
Time Frame: From the day of surgery for 30 days
number of days for patient to first pass flatus or first stool after surgery
From the day of surgery for 30 days
Days to Liquid diet
Time Frame: From the day of surgery for 30 days
number of days for patient to be first started on and tolerate liquids given per-orally, without causing vomiting or abdominal distension
From the day of surgery for 30 days
Days to Solid diet
Time Frame: From the day of surgery for 30 days
number of days for patient to be first started on and tolerate progressively increasing semi-solid diet given per-orally, without causing vomiting or abdominal distension
From the day of surgery for 30 days
Postoperative length of stay
Time Frame: From the day of surgery for 30 days
Number of days for the patient to be discharged from the hospital without complications.
From the day of surgery for 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sawai Mansingh Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

October 5, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Estimate)

March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37/MC/EC/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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