Clinical trial NCT04686032: Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy
Official title: Effect of Early Physical Therapy Interventions on Post-operative Recovery and Complications Following Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Op Complication
Keywords: Abdominal hysterectomy
postoperative pain
Early rehabilitation
Postoperative recovery profile
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 42
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both experimental and control groups will be treated at the same time following their respective protocols
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative recovery profile questionnaire
timeFrame: Post 3rd day
measure: Numeric pain rating scale (NPRS)
timeFrame: Baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: Post 3rd day
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1016/s0004-9514(05)70021-0.
citation: 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.
citation: Reeve JC, Boden I. The physiotherapy management of patients undergoing abdominal surgery. New Zealand Journal of Physiotherapy. 2016;44(1).
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.