NCT02549456

Brief Summary

The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.

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
30

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2015

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

First Submitted

Initial submission to the registry

August 29, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

August 29, 2015

Last Update Submit

March 22, 2017

Conditions

Colorectal Cancer

Keywords

natural orifice surgerynatural orifice specimen extractiontaTME

Outcome Measures

Primary Outcomes (6)

  • Feasibility

    Rate of conversion to classic laparoscopy or to open laparotomy.

    24 hour

  • operative time

    time taken from starting operation till patient wake up

    24 hour

  • Operative blood loss

    measured in milliliter

    24 hour

  • Wound complications

    infection-dehiscence

    two week

  • Major intraoperative complications

    bleeding -organ injury

    24 hour

  • Major postoperative complications

    leak-bleeding

    two weeks

Secondary Outcomes (5)

  • Adequacy of lymphadenectomy

    one month

  • Grading of quality and completeness of mesorectal excision

    one month

  • Longitudinal safety margin

    one month

  • short term oncologic outcome

    6 months - one year

  • Functional outcome

    3 months

Study Arms (2)

Natural orifice specimen extraction

EXPERIMENTAL

Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction

Procedure: natural orifice specimen extraction

Laparoendoscopic resection

EXPERIMENTAL

Laparoscopic assisted transanal endoscopic resection of rectal cancer

Procedure: Laparoendoscopic resection

Interventions

natural orifice specimen extractionPROCEDURE

Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).

Natural orifice specimen extraction
Laparoendoscopic resectionPROCEDURE

Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length. Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed.

Laparoendoscopic resection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medically fit patient.
  • Non metastatic pathologically proven sigmoid colon cancer.
  • Non metastatic pathologically proven rectal cancer.
  • Patient continent for stool.

You may not qualify if:

  • Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
  • Patients with cardiac or chest problems that cannot withstand insufflation.
  • Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
  • Obstructed or perforated cancer.
  • Patients with metastatic colorectal cancer.
  • Incontinent patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology center Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jose F Noguira, MD

    Head of general and digestive surgery department, CHUAC, universidade da Coruna

    STUDY DIRECTOR

  • Sherif Z Kotb, MD

    Professor of surgical oncology, Oncology center Mansoura University

    STUDY CHAIR

Central Study Contacts

Islam H Metwally, M.Sc

CONTACT

01002985865dr.islamo@hotmail.com

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
Assistant lecturer of surgical oncology

Study Record Dates

First Submitted

August 29, 2015

First Posted

September 15, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

EG(1)