Impact of General Anesthesia v/s Spinal Anesthesia on ERAS Parameters in Intestinal Stoma Reversal

NCT06226753 | Not Yet Recruiting

• 1 other identifier: PG Thesis/2023-24/81
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, Interventional ,Open labeled, Parallel Assignment and Superiority trial.

Conditions

Anesthesia; ERAS; Surgical Stomas; Ileostomy - Stoma; Colostomy Stoma

Outcome Measures

Primary Outcomes (1)

• Time to passage of flatus

  Time to passage of first flatus from the time of patient leaving operating room up to 72 hours after surgery will be estimated in hours

  Up to 72 hours after surgery

Secondary Outcomes (3)

• Time to passage of motions

  Up to 1 week after surgery

• Time taken to resumption of oral intake

  Up to 72 hours after surgery

• Time of complete stoppage of IV fluids

  Up to 72 hours after surgery

Other Outcomes (11)

• Postoperative mean Numerical Rating Score

  At 6,12 and 24 hours

• Time to need 1st injectable rescue analgesic i.e. Tramadol

  Up to 72 hours after surgery

• Total number of doses of rescue analgesic used

  Up to 1 week after surgery

Study Arms (2)

Stoma reversal under GA

ACTIVE COMPARATOR

Loop ileostomy closure will be performed under General anaesthesia

Procedure: Type of anaesthesia used

Stoma reversal under SA

EXPERIMENTAL

Loop ileostomy closure will be performed under Spinal anaesthesia

Procedure: Type of anaesthesia used

Interventions

Type of anaesthesia used PROCEDURE

Spinal anaesthesia will be used for closure of loop ileostomy

Also known as: ERAS

Stoma reversal under GA; Stoma reversal under SA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of the patient ;18 years
• Patients with Loop stoma, Double Barrel Stoma or End stoma with
• documented hitched distal loop.
• Patients evaluated and fit for surgery

You may not qualify if:

• Patients requiring mid line laparotomy for stoma reversal
• Patient having active stoma related complications like high output stoma
• and dehydration - Acute Kidney Injury, stoma prolapse, etc making them
• unfit for surgery.
• Patient denying consent for SA or ERAS protocol
• Patient having contraindication for either type of anaesthesia (where
• randomisation would not be possible)
• Patient needing to be converted to GA after pain /discomfort experienced
• by patient or if there was failed spinal anaesthesia
• Patient having abnormal coagulation profile
• Coexistent neurological or psychiatric illness or unable to understand the
• study.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences,

Bhubaneswar, Odisha, 751020, India

Location

Study Officials

• Tushar S Mishra, MBBS MS

  AIIMS Bhubaneswar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tushar S Mishra, MBBS MS

CONTACT

9438884251; doctushar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Allocation: Randomized. Intervention Model: Open labeled, Parallel Assignment, Superiority trial.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 26, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)