Caregiver Support and Post-operative Convalescence

NCT04897061 | Completed

• 1 other identifier: IRB 20-01766
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study designed to investigate the impact of home caregiver support on post-operative convalescence in patients undergoing same day discharge after major urogynecologic surgery. Questionnaires assessing post-operative convalescence will be distributed at several time points after surgery. The main hypothesis is that increased caregiver support in the post-operative period will improve post-operative convalescence of patients undergoing major urogynecologic surgery.

Conditions

Pelvic Organ Prolapse

Keywords

Prolapse; Same day discharge; Caregiver

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Recovery 15 (QOR-15)

  Changes in Quality of Recovery 15 (QOR-15) scores based on a priori caregiver characteristics on post-operative days 3, 7, 14 and 28. QOR-15 is a 15 item instrument, full score range from 0 to 150, with higher score indicating better health outcomes.

  Post-operative day 3, 7, 14, and 28

• Change in Post-discharge Surgical Recovery 13 (PSR-13)

  Changes in Post-discharge Surgical Recovery 13 (PSR-13) scores based on a priori caregiver characteristics on post-operative days 3, 7, 14 and 28.. The PSR scale is a 13 items instrument, full score range from 0-100, with higher score indicating better recovery.

  Post-operative day 3, 7, 14, and 28

Secondary Outcomes (1)

• Change in Healthcare utilization composite score

  Post-operative day 3, 7, 14, and 28

Study Arms (1)

Participants undergoing major pelvic organ prolapse surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female patients are eligible to investigate post-operative recovery and convalescence after urogynecologic surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women age 18 years or older undergoing major pelvic organ prolapse surgery (vaginal apical suspension, laparoscopic or robotic apical suspension, obliterative procedure) or minor prolapse or incontinence procedure with concomitant hysterectomy.

You may qualify if:

• Age 18 years or older
• English speaking
• Successfully discharged on the day of surgery

You may not qualify if:

• Discharge to a nursing home, assisted living or rehabilitation facility.
• Dementia or altered mental status that would make recall of recovery process unreliable.
• Inability to access Internet or phone for study participation

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

Location

Related Publications (14)

• Berg K, Idvall E, Nilsson U, Arestedt KF, Unosson M. Psychometric evaluation of the post-discharge surgical recovery scale. J Eval Clin Pract. 2010 Aug;16(4):794-801. doi: 10.1111/j.1365-2753.2009.01197.x. Epub 2010 Jun 14.

  PMID: 20557414 BACKGROUND

• Kleinbeck SV. Self-reported at-home postoperative recovery. Res Nurs Health. 2000 Dec;23(6):461-72. doi: 10.1002/1098-240X(200012)23:63.0.CO;2-S.

  PMID: 11130605 BACKGROUND

• Lassen PD, Moeller-Larsen H, DE Nully P. Same-day discharge after laparoscopic hysterectomy. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1339-41. doi: 10.1111/j.1600-0412.2012.01535.x. Epub 2012 Oct 17.

  PMID: 22924755 BACKGROUND

• Manohar A, Cheung K, Wu CL, Stierer TS. Burden incurred by patients and their caregivers after outpatient surgery: a prospective observational study. Clin Orthop Relat Res. 2014 May;472(5):1416-26. doi: 10.1007/s11999-013-3270-6.

  PMID: 24005979 BACKGROUND

• Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.

  PMID: 29846193 BACKGROUND

• Wu CL, Berenholtz SM, Pronovost PJ, Fleisher LA. Systematic review and analysis of postdischarge symptoms after outpatient surgery. Anesthesiology. 2002 Apr;96(4):994-1003. doi: 10.1097/00000542-200204000-00030. No abstract available.

  PMID: 11964610 BACKGROUND

• Berg K, Kjellgren K, Unosson M, Arestedt K. Postoperative recovery and its association with health-related quality of life among day surgery patients. BMC Nurs. 2012 Nov 13;11(1):24. doi: 10.1186/1472-6955-11-24.

  PMID: 23148514 BACKGROUND

• Bouwsma EVA, Anema JR, Vonk Noordegraaf A, de Vet HCW, Huirne JAF. Using patient data to optimize an expert-based guideline on convalescence recommendations after gynecological surgery: a prospective cohort study. BMC Surg. 2017 Dec 6;17(1):129. doi: 10.1186/s12893-017-0317-8.

  PMID: 29212492 BACKGROUND

• Carpenter JS, Heit M, Chen CX, Stewart R, Hamner J, Rand KL. Validating the Postdischarge Surgical Recovery Scale 13 as a Measure of Perceived Postoperative Recovery After Laparoscopic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):86-89. doi: 10.1097/SPV.0000000000000352.

  PMID: 28230616 BACKGROUND

• Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

  PMID: 26787793 BACKGROUND

• Dambi JM, Corten L, Chiwaridzo M, Jack H, Mlambo T, Jelsma J. A systematic review of the psychometric properties of the cross-cultural translations and adaptations of the Multidimensional Perceived Social Support Scale (MSPSS). Health Qual Life Outcomes. 2018 May 2;16(1):80. doi: 10.1186/s12955-018-0912-0.

  PMID: 29716589 BACKGROUND

• Evenson M, Payne D, Nygaard I. Recovery at home after major gynecologic surgery: how do our patients fare? Obstet Gynecol. 2012 Apr;119(4):780-4. doi: 10.1097/AOG.0b013e31824bb15e.

  PMID: 22433341 BACKGROUND

• Heit M, Carpenter JS, Chen CX, Stewart R, Hamner J, Rand KL. Predictors of Postdischarge Surgical Recovery Following Laparoscopic Sacrocolpopexy: A Prospective Cohort Study. Female Pelvic Med Reconstr Surg. 2020 May;26(5):320-326. doi: 10.1097/SPV.0000000000000599.

  PMID: 29923843 BACKGROUND

• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

  PMID: 29397134 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Tran, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 24, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)