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Status unknownNCT03096652Updated Mar 30, 2017

A Modified Approach for Morbid Obese With Gynecologic Cancer

An interventional study of Approach for cancer resection in Malignant Neoplasm of Cervix, Endometrium and Ovary, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
01

Study summary

Comparing standard midline approach with the modified approach in management of morbid obese patients with gynecologic cancers.

02

Conditions studied

  • Malignant Neoplasm of Cervix, Endometrium and Ovary

Keywords

  • gynecologic cancer - panniculectomy
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Resectable (ovarian, endometrial, cervical) cancers.
  2. Anaesthetically fit (ASA 1 and 2).
  3. Abdominal pannus below symphysis pubis.

Exclusion criteria

Exclusion Criteria:

  1. Non resectable gynecologic cancer.
  2. Unfit patients.
  3. Patients who refuse to share in the trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Midline approach

    Standard midline incision, then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).

    Procedure: Approach for cancer resection

  • Active comparator
    Modified approach

    Panniculectomy with vertical incision of the rectus sheath then optimal debulking (hysterectomy + lymphadenectomy +/- omentectomy).

    Procedure: Approach for cancer resection

Interventions

  • ProcedureApproach for cancer resection
06

What researchers measure

Primary outcomes

  1. Oncologic outcome

    measured by number of lymph nodes retrieved and rate of optimal debulking.

    Time frame: 2 weeks

Secondary outcomes

  1. Operative time

    Time frame: 1 day

  2. Postoperative procedure related morbidity

    Wound and chest complications

    Time frame: 1 month

  3. Blood loss

    intraoperative

    Time frame: 1 day

  4. Hospital stay

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Oncology center Mansoura University
    Mansoura, Dakahlia 35516, Egypt
    • Islam H Metwally, MSc, MRCS · Contact · drislamhany@mans.edu.eg · 01002985865
    • Ahmed AbdAllah, MD · Sub investigator
    • Amr F Elalfy, MSc · Sub investigator
    • Shadi Awny, MSc · Sub investigator
    • Mohamed Zuhdy, MSc · Sub investigator
    • Mahmoud Mostafa, MSc · Sub investigator
    • Sameh Roshdy, MD · Sub investigator
    • Islam H Metwally, MSc, MRCS · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03096652
Lead sponsor
Mansoura University
Responsible party
Islam Hany Metwally (Assistant lecturer of surgical oncology, Mansoura University) — Principal investigator
First posted
Mar 30, 2017
Start date
Aug 2016
Primary completion
Aug 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Mar 30, 2017

Study contacts

Islam H Metwally, MSc, MRCS
Contact
drislamhany@mans.edu.eg
01002985865 ext. 020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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