NCT07585344

Brief Summary

This prospective randomized comparative study aims to evaluate whether interrupted figure-of-X fascial closure reduces the incidence of burst abdomen compared with continuous suturing in patients undergoing open colorectal laparotomy. Burst abdomen is a serious postoperative complication associated with increased morbidity, prolonged hospital stay, and reoperation. A total of 40 adult patients undergoing elective or emergency colorectal laparotomy will be randomized into two groups: interrupted figure-of-X closure or continuous fascial closure. The primary outcome will be the incidence of burst abdomen within 30 days after surgery. Secondary outcomes will include surgical site infection, seroma, hematoma, and length of hospital stay. The study is being conducted at the Department of General Surgery, Akbar Niazi Teaching Hospital, Islamabad, Pakistan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 7, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

colorectal cancerFigure-of-Eightsurgical wound dehiscence

Outcome Measures

Primary Outcomes (1)

  • THE INCIDENCE OF BURST ABDOMEN

    The number of participants experiencing postoperative disruption of the musculo-fascial layer (complete wound dehiscence) following midline laparotomy.

    UPTO 30 DAYS POST SURGERY

Secondary Outcomes (3)

  • Incidence of Surgical Site Infection (SSI)

    UPTO 30DAYS POST SURGERY

  • Postoperative Seroma and Hematoma Formation

    Up to 30 days post-surgery.

  • Length of Hospital Stay

    From date of surgery until date of discharge (approximately 7-14 days).

Study Arms (2)

interrupted figure of X SUTURE

EXPERIMENTAL

Abdominal wall closure performed using the interrupted 'Figure-of-X' suturing technique. The fascia is closed with interrupted X-shaped sutures using a slowly absorbable monofilament (PDS) or similar material. Each suture involves taking 1 cm tissue bites from the fascial edges with approximately 1 cm intervals between each 'X' to ensure secure mass closure.

Procedure: Interrupted 'Figure-of-X' Suturing Technique

CONTINUOUS MASS CLOSURE

ACTIVE COMPARATOR

: Abdominal wall closure performed using the standard continuous (running) suturing technique. A single-layer continuous mass closure is executed using a slowly absorbable monofilament suture material. The technique involves continuous stitching with approximately 1 cm tissue bites and 1 cm intervals between each loop to ensure an even distribution of tension across the midline incision.

Procedure: CONTINUOUS AMSS CLOSURE

Interventions

For the Figure-of-X: Specify the use of a "slowly absorbable monofilament suture" with "1 cm tissue bites and 1 cm spacing" in an interrupted X-pattern. For the Continuous closure: Specify the use of a "single-layer continuous mass closure" with the same suture material and spacing requirements

interrupted figure of X SUTURE

The abdominal fascia is closed using a standard single- layer continuous (running) mass closure technique. A slowly absorbable monofilament suture is used to provide prolonged tensile strength. The technique follows a continuous suture line with approximately 1 cm tissue bites from the fascial edges and a 1 cm interval between each loop (travel). The suture is started at one end of the incision and continued to the other, ensuring even tension throughout the length of the midline laparotomy wound.

CONTINUOUS MASS CLOSURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (aged 18 years and above).
  • Patients undergoing open laparotomy for histologically confirmed colorectal cancer.
  • Elective surgical procedures.

You may not qualify if:

  • Patients with a previous midline laparotomy within the last 30 days.
  • Patients in whom the abdominal wall is planned to be left open or managed with a temporary closure (open abdomen).
  • Patients with known connective tissue disorders (e.g., Ehlers-Danlos syndrome) that might impair wound healing.
  • Patients with an expected survival of less than 30 days.
  • Emergency laparotomies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamabad Medical and Dental College

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsSurgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
While the operating surgeons cannot be blinded to the technique used, the ward staff (care providers), the outcomes assessor, and the statistician will remain blinded to the group assignment to minimize bias in wound assessment and data analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to undergo abdominal fascial closure using either interrupted figure-of-X suturing or continuous suturing following colorectal laparotomy. Outcomes will be compared between the two parallel study groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start

November 7, 2025

Primary Completion

April 5, 2026

Study Completion

May 15, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

To protect participant privacy and maintain the confidentiality of sensitive medical information related to colorectal cancer treatment, individual participant data (IPD) will not be made available for public sharing. Data collected for this study will be used strictly for the purposes outlined in the study protocol and will only be accessible to the research team and institutional oversight committees. Aggregate results and study outcomes will be shared through peer-reviewed publications and conference presentations.

Locations