Multimodal Prehabilitation Program for Women Undergoing Gynecologic Oncology Surgery

NCT07188662 | Completed DMC

• 1 other identifier: MMPPGOS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the role of multimodal Prehabilitation program on improve surgical outcomes after gynecological oncology surgery.

Conditions

Gynecologic Oncology Patient

Outcome Measures

Primary Outcomes (3)

• changing the postoperative morbidity

  compare the 30 days postoperative morbidity of the prehabilitation and conventional group, it included (Assess the post-operative complications by using Clavien-Dindo classification; from Grade I-IV; higher grades indicate more severe complications.)

  "up to 30 days postoperative"

• changing the postoperative mortality

  compare the 30 days postoperative mortality of the prehabilitation group and conventional group.

  "up to 30 days postoperative"

• Pain intensity measured by the Visual Analog Scale (VAS) for pain.

  compare the 30 days postoperative Pain intensity; Unit of Measure: Units on a scale (0-10 cm). Scale: 0 = no pain, 10 = worst pain imaginable; higher scores indicate worse pain of the prehabilitation group and conventional group.

  "up to 30 days postoperative"

Secondary Outcomes (9)

• change the length of the hospital stay

  up to 5 days post-operative

• Enhance the physical state of gynecological oncology patient using the Eastern Cooperative Oncology Group (ECOG)

  through the postoperative period within two hours up-to 30 days after surgery

• Enhance the psychological wellbeing of gynecological oncology patient

  up-to 15 days preoperatively & up to 30 days post operatively]

• assess and changing the Nutritional Status of the prehabilitation group

  up-to 30 days postoperative

• assess and changing the Nutritional Status of the prehabilitation group

  up-to 30 days postoperative

Study Arms (2)

Conventional group

NO INTERVENTION

Conventional group (woman received hospital care at previous year as a retrospective sample to prevent risk of bias) equal 70 woman

Prehabilitation group

EXPERIMENTAL

Prehabilitation group (woman who will receive prehabilitation care combine with ERAS post-operative care as a prospective sample) equal 70 woman

Procedure: group (B) Prehabilitation care combine with ERAS post-operative care

Interventions

group (B) Prehabilitation care combine with ERAS post-operative care PROCEDURE

intervention will includes receiving prehabilitation care combine with ERAS post-operative care.

Prehabilitation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed woman with gynecologic cancer by imaging \&histopathology
• Accept participation in the study.

You may not qualify if:

• Patient with advanced and metastatic stage
• Patient who received neoadjuvant chemotherapy
• Patient who have psychological disorder such as suicidal attempt
• Patient who have cerebral stroke, hemiplegia or paralyses

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Woman's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Aziza M Mohammed, Head nurse

  Woman's Health Hospital, Assiut University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of maternity, gynecological and obstetric nursing

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: September 23, 2025
• Study Start: April 23, 2024
• Primary Completion: April 23, 2025
• Study Completion: July 23, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)