Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery

a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Procedure: new laparoscopic access technique for group a; Procedure: Hasson's technique for laparoscopic access in group b

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time needed to access the peritoneal cavity	time needed to access the peritoneal cavity	the first 15 minutes of operation
numbers of trials till the good peritoneal access achieved	numbers of trials till the good peritoneal access achieved	the first 15 minutes of operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of complications	rate of complications	the first 15 minutes of operation

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): July 17, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: zuh248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No