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Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05565508
Collaborator
(none)
172
Enrollment
1
Location
2
Arms
28
Actual Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery

Condition or Disease Intervention/Treatment Phase
  • Procedure: new laparoscopic access technique for group a
  • Procedure: Hasson's technique for laparoscopic access in group b
 N/A

Detailed Description

the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
Actual Study Start Date :
Mar 20, 2020
Actual Primary Completion Date :
Jul 17, 2022
Actual Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: new laparoscopic access technique

in which we used our new laparoscopic access

Procedure: new laparoscopic access technique for group a
new laparoscopic access technique through the epigastric region
Other Names:
  • new laparoscopic access technique

    		•
    Experimental: Hasson's technique

    in which we used the well-known Hasson's technique for primary laparoscopic access

    Procedure: Hasson's technique for laparoscopic access in group b
    Hasson's technique for laparoscopic access in group b

    Outcome Measures

    Primary Outcome Measures

    1. time needed to access the peritoneal cavity [the first 15 minutes of operation]

      time needed to access the peritoneal cavity

    2. numbers of trials till the good peritoneal access achieved [the first 15 minutes of operation]

      numbers of trials till the good peritoneal access achieved

    Secondary Outcome Measures

    1. rate of complications [the first 15 minutes of operation]

      rate of complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.

    • underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.

    Exclusion Criteria:

    • Patients with distended abdomen due to bowel obstruction.

    • Patients with uncorrected coagulopathy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University Zagazig Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed lotfy, prof. Dr, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05565508
    Other Study ID Numbers:
    • zuh248
    First Posted:
    Oct 4, 2022
    Last Update Posted:
    Oct 4, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 4, 2022