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

NCT05753709 | Completed

• 1 other identifier: 37/MC/EC/2021
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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:

1. 1.EE: Conventional Hand-sewn end-to-end anastomosis, and
2. 2.SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:
3. 3.HSSA: Hand-sewn side-to-side anastomosis
4. 4.SSSA: Stapled side-to-side anastomosis
5. 5.Rates of major post-operative complications
6. 6.Rates of short-term complications (within 30 days of surgery)
7. 7.Rates of re-operation
8. 8.Post-operative length of stay in the hospital

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Operating Time

  Intraoperatively

• Number of participants with Wound Infection

  From the day of surgery for 30 days

• Number of participants with Anastomotic Bleeding

  From the day of surgery for 30 days

• Number of participants with Anastomotic Stricture

  From the day of surgery for 30 days

• Number of participants with Intra-abdominal Collection

  From the day of surgery for 30 days

Other Outcomes (4)

• Days to Bowel Movement

  From the day of surgery for 30 days

• Days to Liquid diet

  From the day of surgery for 30 days

• Days to Solid diet

  From the day of surgery for 30 days

Study Arms (3)

EE

ACTIVE COMPARATOR

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

Procedure: Hand sewn end-to-end anastomosis

SSSA

ACTIVE COMPARATOR

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

Procedure: Stapled side-to-side anastomosis

HSSA

ACTIVE COMPARATOR

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

Interventions

Hand sewn end-to-end anastomosis PROCEDURE

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.

EE

Hand sewn side-to-side anastomosis PROCEDURE

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.

HSSA

Stapled side-to-side anastomosis PROCEDURE

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.

SSSA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sawai Mansingh Medical College: lead

Study Sites (1)

Sawai Mansingh Medical College and Hospital

Jaipur, Rajasthan, 302004, India

Location

Related Publications (23)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Ileus; Anastomotic Leak; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident, Principal Investigator

Model Details: two groups in parallel: EE and SS, and another comparison with three arms: EE versus SS divided into two separate arms: SSSA and HSSA

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 3, 2023
• Study Start: January 1, 2022
• Primary Completion: October 5, 2022
• Study Completion: October 30, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

IN (1)