NCT07321743

Brief Summary

The goal of this clinical trial is to compare the outcomes of emergency intestinal anastomosis after stapled and handsewn anastmosis. The main question it aims to answer are: Is stapled intestinal anastmosis is better than handsewn anastmosis in emergency laparotomy? Participants at surgical emergency unit:

  • Had intestinal anastmosis either by stapler or handsewn.
  • kept in hospital for follow up and detection of complications like wound infection and leakage.
  • Either discharged or managed according to the complications
  • Outcomes were compared between the two groups

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 22, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

staplerhandsewnanastomotic leakageintestinal obstruction

Outcome Measures

Primary Outcomes (1)

  • intestinal leakage

    intestinal leakage output calculated in ml by weighing dressing or calculating the drain output

    from one day to two weeks after surgery

Secondary Outcomes (4)

  • operation time

    from incision time to closure (0 to 5 hours)

  • bleeding

    from one hour to two days after surgery

  • hospital stay

    from one day to one month after surgery

  • post-operative pain

    from one to three days after after surgery

Study Arms (2)

stapled group

ACTIVE COMPARATOR
Procedure: emergency intestinal anastmosis surgery

handsewn group

ACTIVE COMPARATOR
Procedure: emergency intestinal anastmosis surgery

Interventions

cases with intestinal trauma, perforation or intestinal obstruction had emergency laparotomy and intestinal anastmosis was done

handsewn groupstapled group

Eligibility Criteria

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

You may qualify if:

  • patients admitted to emergency surgery and needed intestinal anastmosis

You may not qualify if:

  • patients below 18 years old
  • immune-compromised patients e.g. corticosteroids therapy, autoimmue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Anastomotic LeakIntestinal Obstruction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of general surgery, Zagazig University

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

December 20, 2024

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Locations