NCT07681700

Brief Summary

The aim of the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

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 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 27, 2026

Last Update Submit

June 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of patients suffering from Seroma

    Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.

    6 months post-procedure

Secondary Outcomes (4)

  • Degree of pain

    24 hours post-procedure

  • Degree of patient satisfaction

    24 hours post-procedure

  • Measurement of operative time

    Till closure of the skin (Up to 60 minutes).

  • Incidence of recurrence

    6 months post-procedure

Study Arms (2)

Group A

EXPERIMENTAL

Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.

Procedure: Trans-abdominal preperitoneal repair + Drainage

Group B

EXPERIMENTAL

Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.

Procedure: Trans-abdominal preperitoneal repair

Interventions

Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.

Group A

Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.

Group B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged from18 to 70 years.
  • Both sexes.
  • Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.

You may not qualify if:

  • Previous history of pelvic or lower abdominal surgery.
  • Coagulopathy.
  • Any condition contraindicating laparoscopic surgery.
  • Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
  • Active infections.
  • Uncorrected medical comorbidities.
  • Bilateral inguinal hernia either preoperative or intraoperative diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Seroma

Interventions

Drainage

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

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
MSc Candidate in General Surgery, Faculty of Medicine, Cairo University, Giza, Egypt

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 2, 2026

Study Start

December 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations