Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit

Completed

• Conditions: Surgery; Hemorrhoids

• Registration Number: NCT04567485
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

The target rate for outpatient surgery has been set by the Ministry of Health at 70% for 2020. To achieve this objective, this requires increasing the panel of eligible outpatient procedures to more mutilating surgeries and usually performed in conventional hospitalization. This switch from conventional hospitalization to an outpatient stay increases the risk of converting stays into unscheduled hospitalization. Postoperative pain is one of the main factors in converting outpatient stays. Poor control is associated with increased length of stay, and unscheduled consultations and readmissions. In addition, the increased time spent with severe pain during the first 24 hours postoperatively is a risk factor for chronicization.

Proctology, and, in particular, hemorrhoidal surgery is the perfect example. Outpatient management of open pedicle hemorrhoidectomy is increasing year by year, but the rate of conversion to unscheduled hospitalizations remains high. Urine retention, postoperative hemorrhage and poor pain control are the main causes. Within the Paris Saint Joseph Hospital Group, hemorrhoidal surgery has the highest rate of conversions from hospitalization to proctology (8% in 2019), despite the implementation since 2015 of a dedicated, developed according to the current recommendations of the SNFCP.

The pain after hemorrhoidal surgery is always severe in the absence of analgesics and appears upon arrival in the post-interventional monitoring room (SSPI). Despite the administration of analgesics or the implementation of locoregional analgesia techniques (pudendal block), moderate to severe pain is frequently observed in the post-intervention monitoring room. In the medical literature, there is little data evaluating the means of management of postoperative pain in this surgery, and even less the effect of the different associations.

Retrospectively and, from the data collected in our information systems, we wish to assess the impact on the length of stay of the presence of moderate to severe pain in the IPSS after a two-way or tri-pedicle hemorrhoidal surgery open on our cohort of patients operated in outpatient surgery. Our hypothesis is that the presence of moderate to severe pain in PPSS increases the total length of stay, placing the patient at an increased risk of conversion. The purpose of our study is also to identify predictive factors (aggravating or protective) of the onset of moderate to severe pain immediately after surgery, in order to establish a strategy to limit its frequency.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2020-10-01
• Primary Completion: 2020-11-01
• Status Verified: 2023-04
• Study Completion: 2023-04-26
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• Patient whose age is ≥ 18 years
• Patient scheduled for outpatient hospitalization,
• Patient operated on for open hemorrhoidectomy surgery, between January 01, 2019 and December 31, 2019
• French-speaking patient

Exclusion Criteria

• Patient scheduled for conventional hospitalization
• Patient not having an anesthesia report in DxCare®
• Patient not having a report of passage in SSPI in DxCare ®
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection
• Patient objecting to the use of his medical data in the context of this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of moderate to severe pain postoperatively from an open bi- or tri-pedicular hemorrhoidectomy scheduled on an outpatient basis	Day 30	This outcome corresponds to the total length of stay of the patient within the Paris Saint Joseph Hospital, obtained by calculating the difference between the date and time of discharge from the hospital, and the date and time of entry into the Ambulatory Surgery Unit .

Secondary Outcome Measures

Name	Time	Method
Length of stay in SSPI	Day 30	This outcome corresponds to the duration of stay in SSPI calculated from the difference between the time of exit and the time of entry into SSPI.
Independent predictive factors that reduce or increase the risk of moderate to severe pain	Day 30	This outcome corresponds to the evaluatiob of predictive factors that reduce or increase the risk of moderate to severe pain.
Conversion rate from hospital to outpatient to conventional hospitalization	Day 30	This outcome corresponds to the conversion rate calculated by the ratio between the number of patients whose scheduled outpatient stay is transformed into conventional hospitalization over the total number of patients scheduled as outpatient.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France