Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

NCT ID: NCT04686032

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-07-30

Brief Summary

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Variety of physical therapy treatments have been used after open abdominal surgery to improve cardiopulmonary and physical function as well as to reduce the incidence of postoperative pulmonary complications. This study intends to determine the effect of early physical therapy interventions on post-operative recovery profile, post-operative ileus and incisional pain following abdominal hysterectomy.

Detailed Description

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This study is randomized controlled trial which will be conducted at in-patient gynecology department of Pakistan Railway hospital. This study would include total of 42 participants divided into two groups with 21 participants in each group calculated through OpenEpi (CI=95%Power=80%). Individuals will be screened according to inclusion and exclusion criteria and allocated randomly into two groups through sealed envelope method. Experimental group will receive early physical therapy interventions including patient education, ambulation, in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during the first 3 post-operative days following abdominal hysterectomy. While the control group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy.

Post-operative recovery will be assessed on 3rd post-operative day. Intensity of pain will be measured on baseline and 3rd post-operative day. The effect of intervention on post-operative ileus will be measured by monitoring each participant's time to tolerance of oral diet, first passage of stool and flatus

Conditions

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Post-Op Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Both experimental and control groups will be treated at the same time following their respective protocols
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.

Study Groups

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Advanced Rehab Group

The experimental group will receive early physical therapy interventions including patient education, ambulation, in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during the first 3 post-operative days following abdominal hysterectomy

Group Type EXPERIMENTAL

Advanced early Rehabilitation Program

Intervention Type OTHER

Patient education, Ambulation, In bed exercises, Deep breathing exercises: (5 rep x 3set), Connective tissue manipulation for intestinal motility (5 min) and TENS\* for incisional pain (30min)

Early ambulation Group

Participants of this group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy

Group Type ACTIVE_COMPARATOR

Early ambulation

Intervention Type OTHER

Patient education \& Assisted ambulation out of bed including walking away from bedside for at least 15 min gradually moving to Unsupervised ambulation for 30 min

Interventions

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Advanced early Rehabilitation Program

Patient education, Ambulation, In bed exercises, Deep breathing exercises: (5 rep x 3set), Connective tissue manipulation for intestinal motility (5 min) and TENS\* for incisional pain (30min)

Intervention Type OTHER

Early ambulation

Patient education \& Assisted ambulation out of bed including walking away from bedside for at least 15 min gradually moving to Unsupervised ambulation for 30 min

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* open abdominal hysterectomy
* Patient awake and responsive, stable blood pressure, stable heart rate, no dyspnea at rest and pain score \< 8 on visual analogue scale on first post-operative day.
* No limitation on physical activities due to any medical problem or restriction by the physician.

Exclusion Criteria

* Other hysterectomy procedures i.e. laparoscopic or vaginal hysterectomy.
* Females with diabetes or cancer of metastatic nature.
* Neurological or cognitive deficit.
* Ongoing respiratory problem prior to initiation of physical therapy session.
* Medical recommendation not to participate in early active rehabilitation
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huma Riaz

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Railway hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Citak Karakaya I, Yuksel I, Akbayrak T, Demirturk F, Karakaya MG, Ozyuncu O, Beksac S. Effects of physiotherapy on pain and functional activities after cesarean delivery. Arch Gynecol Obstet. 2012 Mar;285(3):621-7. doi: 10.1007/s00404-011-2037-0. Epub 2011 Aug 10.

Reference Type BACKGROUND
PMID: 21830007 (View on PubMed)

Allvin R, Svensson E, Rawal N, Ehnfors M, Kling AM, Idvall E. The Postoperative Recovery Profile (PRP) - a multidimensional questionnaire for evaluation of recovery profiles. J Eval Clin Pract. 2011 Apr;17(2):236-43. doi: 10.1111/j.1365-2753.2010.01428.x. Epub 2010 Sep 16.

Reference Type BACKGROUND
PMID: 20846316 (View on PubMed)

Mackay MR, Ellis E, Johnston C. Randomised clinical trial of physiotherapy after open abdominal surgery in high risk patients. Aust J Physiother. 2005;51(3):151-9. doi: 10.1016/s0004-9514(05)70021-0.

Reference Type BACKGROUND
PMID: 16137240 (View on PubMed)

Hanekom SD, Brooks D, Denehy L, Fagevik-Olsen M, Hardcastle TC, Manie S, Louw Q. Reaching consensus on the physiotherapeutic management of patients following upper abdominal surgery: a pragmatic approach to interpret equivocal evidence. BMC Med Inform Decis Mak. 2012 Feb 6;12:5. doi: 10.1186/1472-6947-12-5.

Reference Type BACKGROUND
PMID: 22309427 (View on PubMed)

Reeve JC, Boden I. The physiotherapy management of patients undergoing abdominal surgery. New Zealand Journal of Physiotherapy. 2016;44(1).

Reference Type BACKGROUND

Castelino T, Fiore JF Jr, Niculiseanu P, Landry T, Augustin B, Feldman LS. The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Surgery. 2016 Apr;159(4):991-1003. doi: 10.1016/j.surg.2015.11.029. Epub 2016 Jan 21.

Reference Type BACKGROUND
PMID: 26804821 (View on PubMed)

Other Identifiers

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REC/00834 Zarfasheen Zia

Identifier Type: -

Identifier Source: org_study_id

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