Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

NCT04686032 | Completed

• 1 other identifier: REC/00834 Zarfasheen Zia
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Op Complication

Keywords

Abdominal hysterectomy; postoperative pain; Early rehabilitation; Postoperative recovery profile

Outcome Measures

Primary Outcomes (3)

• Postoperative recovery profile questionnaire

  For hospitalized patients a 17-item version of the PRP will be used (excluding the items "Re-establishing everyday life" and "Sexual activity"). The global score ranges from 0 to 17.

  Post 3rd day

• Numeric pain rating scale (NPRS)

  Numeric pain rating scale (NPRS) will be used for evaluating intensity of the incisional pain. Its scores range from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

  Baseline

• Numeric pain rating scale (NPRS)

  Numeric pain rating scale (NPRS) will be used for evaluating intensity of the incisional pain. Its scores range from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

  Post 3rd day

Study Arms (2)

Advanced Rehab Group

EXPERIMENTAL

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

Other: Advanced early Rehabilitation Program

Early ambulation Group

ACTIVE COMPARATOR

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

Other: Early ambulation

Interventions

Advanced early Rehabilitation Program 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)

Advanced Rehab Group

Early ambulation 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

Early ambulation Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Female patients after abdominal hysterectomies will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 21830007 BACKGROUND

• 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.

  PMID: 20846316 BACKGROUND

• 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.

  PMID: 16137240 BACKGROUND

• 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.

  PMID: 22309427 BACKGROUND

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

  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.

  PMID: 26804821 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Pain, Postoperative

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Huma Riaz

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both experimental and control groups will be treated at the same time following their respective protocols

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)