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

Primary Purpose

Stoma Ileostomy, Stoma Colostomy, Anastomosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Hand sewn end-to-end anastomosis
Hand sewn side-to-side anastomosis
Stapled side-to-side anastomosis
Sponsored by
Sawai Mansingh Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stoma Ileostomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sawai Mansingh Medical College and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

EE

SSSA

HSSA

Arm Description

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

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

Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation

Outcomes

Primary Outcome Measures

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
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.
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.
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

Secondary Outcome Measures

Operating Time
Time during surgery from incision to skin closure
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
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.
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).
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.
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
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.
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.

Full Information

First Posted
February 13, 2023
Last Updated
February 22, 2023
Sponsor
Sawai Mansingh Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05753709
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sawai Mansingh Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stoma Ileostomy, Stoma Colostomy, Anastomosis, Ileus, Leak, Anastomotic, Bowel Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EE
Arm Type
Active Comparator
Arm Description
End-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures
Arm Title
SSSA
Arm Type
Active Comparator
Arm Description
Stapled side-to-side anastomosis of the stoma using a linear cutter stapling device
Arm Title
HSSA
Arm Type
Active Comparator
Arm Description
Hand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation
Intervention Type
Procedure
Intervention Name(s)
Hand sewn end-to-end anastomosis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hand sewn side-to-side anastomosis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stapled side-to-side anastomosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with Post-operative Ileus (POI)
Description
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
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Anastomotic Leak
Description
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.
Time Frame
From the day of surgery for 30 days
Title
Number of participants with complications of Clavien-Dindo grade higher than 2
Description
Number of participants with complications developing post-operatively of Clavien-Dindo grade higher than 2, suggestive of a severe complication.
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Bowel Obstruction
Description
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
Time Frame
From the day of surgery for 30 days
Secondary Outcome Measure Information:
Title
Operating Time
Description
Time during surgery from incision to skin closure
Time Frame
Intraoperatively
Title
Number of participants with Wound Infection
Description
Number of participants with Infection of the incision site ranging from simple local purulent collection to overt infection requiring re-operation
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Anastomotic Bleeding
Description
Number of participants with Evidence of bleeding around the anastomotic site, confirmed by a complaint of melena, or radiological or endoscopic findings.
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Anastomotic Stricture
Description
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).
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Intra-abdominal Collection
Description
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.
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Re-operation
Description
Number of participants developing complications severe enough and not responding to medical management, that needed to be re-operated
Time Frame
From the day of surgery for 30 days
Title
Number of participants with Organ Dysfunction for each individual organ
Description
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.
Time Frame
From the day of surgery for 30 days
Title
Overall Morbidity
Description
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.
Time Frame
From the day of surgery for 30 days
Other Pre-specified Outcome Measures:
Title
Days to Bowel Movement
Description
number of days for patient to first pass flatus or first stool after surgery
Time Frame
From the day of surgery for 30 days
Title
Days to Liquid diet
Description
number of days for patient to be first started on and tolerate liquids given per-orally, without causing vomiting or abdominal distension
Time Frame
From the day of surgery for 30 days
Title
Days to Solid diet
Description
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
Time Frame
From the day of surgery for 30 days
Title
Postoperative length of stay
Description
Number of days for the patient to be discharged from the hospital without complications.
Time Frame
From the day of surgery for 30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sawai Mansingh Medical College and Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India

12. IPD Sharing Statement

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

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