NCT04972994

Brief Summary

The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 6, 2021

Last Update Submit

July 21, 2021

Conditions

Keywords

laparoscopicintracorporealextracorporealanastomosishemicolectomies, colonic cance

Outcome Measures

Primary Outcomes (4)

  • intraoperative time of surgery

    intraoperative time of surgery by minutes

    intraoperative time of surgery

  • post operative hospital stay

    post operative hospital stay by days

    up to 1 year

  • Post operative leakage

    Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect \& wound infection

    1 year

  • early recurrence of the cancer

    early recurrence of the cancer by CT scan

    6 months after surgery

Study Arms (2)

laparoscopic intracorporeal anastomosis for right and left hemicolectomies

ACTIVE COMPARATOR

Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers

Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies

laparoscopic extracorporeal anastomosis for right and left hemicolectomies

ACTIVE COMPARATOR

Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies

Interventions

laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

laparoscopic extracorporeal anastomosis for right and left hemicolectomieslaparoscopic intracorporeal anastomosis for right and left hemicolectomies

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients had to present histologically confirmed cancer( right and left) colon.
  • All grades of cancer will be included.
  • Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.

You may not qualify if:

  • Locally advanced disease with invasion of adjacent important organs.
  • Acute bowel obstruction or perforation from cancer.
  • Pregnant ladies.
  • Rectal cancer and transverse colon cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Omar AS Al tabary, Professor

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

Abdullah AA Abdullah, M.B.B.Ch,M.Sc

CONTACT

Omar AS AlTabary, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: right and left hemicolectomies in colonic cancers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecture general surgery

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 22, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations