Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

Post-Op Complication Clinical Trial

Official title:

Effect of Early Physical Therapy Interventions on Post-operative Recovery and Complications Following Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686032
• Other study ID #: REC/00834 Zarfasheen Zia
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: September 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Op Complication
• Postoperative Complications

Intervention

Other:
• 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)
• 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

Locations

Country	Name	City	State
Pakistan	Pakistan Railway hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

Çitak Karakaya I, Yüksel I, Akbayrak T, Demirtürk F, Karakaya MG, Ozyüncü Ö, Beksaç 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. — View Citation

Hanekom SD, Brooks D, Denehy L, Fagevik-Olsén 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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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