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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.
Pelvic organ prolapse and incontinence surgery is now often done on an outpatient basis (also known as same day discharge surgery or SDD). While there are data to support the safety of this practice, little is known about the burden and demands of this practice on the patient and her support system/caregivers. Furthermore, there are no guidelines on requirements for assistance at home or what impact home caregiver support has on recovery. The study team is interested in investigating the spectrum of support that patients have at home in terms of caregivers such as family, friends, neighbors and how that may impact their recovery. The intervention for this study will be comprised of administering post-operative questionnaires that assess patients' post-operative convalescence and quantify the required or available caregiver support. The clinical outcome of interest is recovery as assessed by the validated questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing major pelvic organ prolapse surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Healthcare utilization composite score | Changes in a composite score comprised of healthcare utilization of phone calls, unanticipated office visits, and emergency department (ED) visits based on a priori caregiver characteristics on post-operative day 3, 7, 14, and 28. | Post-operative day 3, 7, 14, and 28 |
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Inclusion Criteria:
Exclusion Criteria:
Only female patients are eligible to investigate post-operative recovery and convalescence after urogynecologic surgery.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ann Tran, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20557414 | Background | 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. | |
| 11130605 | 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. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 22924755 | 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. |
| 24005979 | 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. |
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| 28230616 | 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. |
| 26787793 | 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. |
| 29716589 | 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. |
| 22433341 | 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. |
| 29923843 | 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. |
| 29397134 | 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. |