Comparison Between Single Port Versus Conventional Lap Appendectomy

Sponsor

Abanoub Atif Fawzy (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05611489

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

comparison the safety and feasibility of single-port laparoscopic appendectomy with conventional laparoscopic appendectomy and post operative hospital stay and complications that may happen .

Condition or Disease	Intervention/Treatment	Phase
Appendicitis Acute	Procedure: Single port Lap appendectomy Procedure: Conventional Lap appendectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single lap appendectomy Conventional lap appendectomySingle lap appendectomy Conventional lap appendectomy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison Between Single Port Versus Conventional Lap Appendectomy

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Single port Lap appendectomy A multiport device will be introducted through a 2-2.5 transumbilical incision.	Procedure: Single port Lap appendectomy A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
Other: Conventional lap appendectomy Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic).	Procedure: Conventional Lap appendectomy Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end. Other Names: Multiport Lap appendectomy

Arm

Intervention/Treatment

Other: Single port Lap appendectomy

A multiport device will be introducted through a 2-2.5 transumbilical incision.

Procedure: Single port Lap appendectomy

A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.

Other: Conventional lap appendectomy

Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic).

Procedure: Conventional Lap appendectomy

Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.

Other Names:

Multiport Lap appendectomy

Outcome Measures

Primary Outcome Measures

Operative time [1 year]
Time needed for operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient age between 5-50 year old
patient diagnosed as acute appendicitis

Exclusion Criteria:

pregnacy
perforated appendix
severe obese patient
bleeding disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Abanoub Atif Fawzy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abanoub Atif Fawzy, Principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05611489

Other Study ID Numbers:

Single port Lap appendectomy

First Posted:

Nov 10, 2022

Last Update Posted:

Nov 10, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Abanoub Atif Fawzy, Principle investigator, Assiut University

Single port

Additional relevant MeSH terms:

Appendicitis

Study Results

No Results Posted as of Nov 10, 2022