NCT06196138

Brief Summary

The passage discusses the recovery of gastrointestinal (GI) function after abdominal surgery and the potential impact on patient comfort. After surgery, small bowel activity typically returns to normal within a few hours, gastric activity within 24-48 hours, and colonic activity within 48-72 hours. However, the delayed mobility of the GI system postoperatively can lead to issues such as abdominal bloating, nausea, vomiting, and pain. These symptoms can negatively affect patient comfort, leading to increased post-operative pain, decreased mobility, reduced satisfaction, and a longer hospital stay. Therefore, interventions that expedite the normalization of bowel activity are crucial. Chewing is suggested to stimulate intestinal motility by activating the cephalovagal pathway, which influences neurogenic and hormonal factors regulating GI functions. Postoperative heat application aims to prevent hypothermia, enhance bodily functions, and potentially promote bowel motility by stimulating somatic nerves. The study explores the effects of gum chewing and hot application protocols on postoperative pain, bowel function, and patient comfort after gynecologic oncologic surgery. It aims to contribute valuable insights to the existing literature on postoperative outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

December 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

December 22, 2023

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    This scale, which can be used horizontally or vertically, is shaped like a 10 cm line. The scale begins with "No pain" and ends with "My pain is very severe. The person is asked to select a number between 0 and 10 that corresponds to the pain they feel on this scale.

    8 months

  • General Comfort Scale

    The highest total score that can be obtained from the scale is 192 and the lowest total score is 48. Obtained The total score depends on the number of scale items.

    8 months

Study Arms (3)

Gum

EXPERIMENTAL

Patients who will chew gum after surgery will constitute this group

Other: Gum

Hot Compress

EXPERIMENTAL

Patients who will undergo hot compress after surgery will constitute this group

Other: Hot Compress

Control

NO INTERVENTION

Patients who will undergo routine protocol will constitute this group

Interventions

GumOTHER

In the postoperative period, starting from the 4th hour, chewing gum is done 3 times a day, morning, noon and evening, for 30 minutes each, until the patient passes the first flatus.

Gum

Starting from the 1st postoperative day, patients will receive hot application (to the lumbar region) for 10 minutes in the morning and evening. The hot application is applied by wrapping 2 towels in a water bag containing 55 ± 2 °C hot water. The water bag is applied to the lumbar region for 10 minutes with the patient in the supine position. The application is continued until the patient passes the first flatus.

Hot Compress

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly patients of the female gender will be included, as they are patients undergoing gynecological surgery.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • To undergo elective minimally invasive gynecologic surgery
  • No cognitive, affective and mental problems that would prevent gum chewing and hot application
  • Does not have any chronic disease
  • No previous abdominal surgery
  • Turkish speaking and
  • Women who volunteer to participate in the study will be included.

You may not qualify if:

  • Who wants to leave the work for any reason
  • History of ileostomy and colostomy
  • He was taken to intensive care after the surgery and
  • Women with postoperative complications (bleeding, infection, etc.) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yalcin Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • Akladios C, Darai E, Golfier F, Lecuru F, Collinet P, Uzan C, Lavoue V, Guyon F, Ferron G, Querleu D. [National certification for gynecological cancer surgery]. Bull Cancer. 2021 Sep;108(9):806-812. doi: 10.1016/j.bulcan.2021.03.019. Epub 2021 Jun 30. French.

    PMID: 34217437BACKGROUND
  • Schneider S, Armbrust R, Spies C, du Bois A, Sehouli J. Prehabilitation programs and ERAS protocols in gynecological oncology: a comprehensive review. Arch Gynecol Obstet. 2020 Feb;301(2):315-326. doi: 10.1007/s00404-019-05321-7. Epub 2019 Oct 15.

    PMID: 31616986BACKGROUND
  • Nanthiphatthanachai A, Insin P. Effect of Chewing Gum on Gastrointestinal Function Recovery After Surgery of Gynecological Cancer Patients at Rajavithi Hospital: A Randomized Controlled Trial. Asian Pac J Cancer Prev. 2020 Mar 1;21(3):761-770. doi: 10.31557/APJCP.2020.21.3.761.

    PMID: 32212805BACKGROUND
  • Phutsisen J, Kietpeerakool C, Jampathong N, Chumworathayi B, Temtanakitpaisan A, Aue-Aungkul A, Boontasaeng P. Effects of Cassia alata Linn on bowel function recovery following surgery for gynecological cancer: A randomized controlled trial. Complement Ther Med. 2019 Dec;47:102222. doi: 10.1016/j.ctim.2019.102222. Epub 2019 Oct 21.

    PMID: 31779993BACKGROUND
  • Yin YN, Xie H, Ren JH, Jiang NJ, Dai L. The impact of gum-chewing on postoperative ileus following gynecological cancer surgery: A systematic review and meta-analysis of randomized controlled trials. Front Oncol. 2023 Jan 17;12:1059924. doi: 10.3389/fonc.2022.1059924. eCollection 2022.

MeSH Terms

Conditions

Pain

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Merve Beke, MSc

    Dr. Abdurrahman Yalcin Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 9, 2024

Study Start

January 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

March 27, 2026

Record last verified: 2024-03

Locations