Pelvic Organ ProlapseNCT04897061
Caregiver Support and Post-operative Convalescence
An observational study of Pelvic Organ Prolapse, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18 years or older
- English speaking
- Successfully discharged on the day of surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10128
About this study
Official title: Impact of Home Support on Quality of Post-operative Recovery After Major Pelvic Organ Prolapse Surgery
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.
Read the detailed description
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.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Prolapse, Same day discharge, Caregiver
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing major pelvic organ prolapse surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-operative day 3, 7, 14, and 28
Secondary outcomes (1)
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.
Measured: Post-operative day 3, 7, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start24 May 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Tran, Icahn School of Medicine at Mount Sinai
- Investigators
- Ann Tran, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897061
- Sponsor's protocol ID
- IRB 20-01766
- Status last verified
- Nov 2022
- First submitted
- 18 May 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20557414Kleinbeck 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.
PubMed 11130605Lassen 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.
PubMed 22924755Manohar 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.
PubMed 24005979Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.
PubMed 29846193Wu 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.
PubMed 11964610Berg 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.
PubMed 23148514Bouwsma 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.
PubMed 29212492Carpenter 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.
PubMed 28230616Chazapis 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.
PubMed 26787793Dambi 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.
PubMed 29716589Evenson 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.
PubMed 22433341Heit 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.
PubMed 29923843Kleif 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.
PubMed 29397134
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home Support on Quality of Post-operative Recovery After Major Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT04897061
- Acronym / sponsor ID
- IRB 20-01766
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Prolapse, Same day discharge, Caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing major pelvic organ prolapse surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years or older
- English speaking
- Successfully discharged on the day of surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Recovery 15 (QOR-15)
Time frame: Post-operative day 3, 7, 14, and 28
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.
Change in Post-discharge Surgical Recovery 13 (PSR-13)
Time frame: Post-operative day 3, 7, 14, and 28
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.
1 secondary outcome
Change in Healthcare utilization composite score
Time frame: Post-operative day 3, 7, 14, and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Background: PubMed 20557414Berg 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.
- Background: PubMed 11130605Kleinbeck 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.
- Background: PubMed 22924755Lassen 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.
- Background: PubMed 24005979Manohar 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.
- Background: PubMed 29846193Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.
- Background: PubMed 11964610Wu 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.
- Background: PubMed 23148514Berg 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.
- Background: PubMed 29212492Bouwsma 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.
- Background: PubMed 28230616Carpenter 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.
- Background: PubMed 26787793Chazapis 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.
- Background: PubMed 29716589Dambi 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.
- Background: PubMed 22433341Evenson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Tran, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Recovery 15 (QOR-15) (time frame: Post-operative day 3, 7, 14, and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897061, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.