Responsiveness of the Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score in patients with haemorrhoidal disease.

AIM: In this study we aimed to assess the responsiveness of the symptom score of the recently developed Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS). Furthermore, the minimally relevant difference (MRD) was determined. METHOD: The responsiveness of PROM-HISS was tested using a criterion-based (i.e. anchor) and construct-based (i.e. hypotheses testing) approach. Patients with haemorrhoidal disease (HD) completed the PROM-HISS before and 1 week after treatment in hospital. A global self-assessment of change question (SCQ) was administered 1-week after treatment and functioned as the criterion. The following analyses were performed: (1) correlation between the PROM-HISS symptom score and the criterion (SCQ) and (2) hypotheses testing. The MRD was determined as change in symptoms of the subgroup reporting 'somewhat fewer complaints' on the SCQ. RESULTS: Between February and August 2022, 94 patients with grade II-IV HD from three hospitals were included. The correlation between the SCQ and a change on the PROM-HISS symptom score was 0.595 indicating that an improvement on the SCQ corresponds to an improvement on the PROM-HISS symptom score. As hypothesized, the mean change in PROM-HISS scores was significantly different between subgroups of patients based on their SCQ responses. Patients reporting a small change in HD symptoms on the SCQ corresponded to a mean change of 0.3 on the PROM-HISS symptom score. CONCLUSION: The PROM-HISS symptom score is a responsive instrument as it identifies change in HD symptoms because of treatment. The estimated MRD of 0.3 can be used to inform clinical research and practice.

Reversal of left-sided colostomy utilizing single-port laparoscopy: single-center consolidation of a new technique.

BACKGROUND: Considerable morbidity (10-14%) and even mortality (4-30%) have been reported after reversal of intestinal continuity following Hartmann's procedure. Feasibility of and advantages in reducing peri- and postoperative morbidity by utilizing single-port techniques through the colostomy site have been suggested before in small case series. The purpose of the present prospective observational study is to evaluate the outcomes of reversal of intestinal continuity using single-port access in a relatively large consecutive cohort. METHODS: All consecutive patients undergoing single-port reversal of left-sided colostomy (SPRLC) between November 2012 and 2018 were included in the present study. Primary outcome was 30-day postoperative complication rate. Secondary outcomes were postoperative length of stay, single-port success rate, and surgical details like duration and conversion rates. RESULTS: Of 85 procedures, 69.4% were without postoperative complications. No postoperative mortality was encountered. Superficial site infection is the most frequent complication and occurred in 22.4%, major complications classified as Clavien-Dindo grade 3 or above in 9.4% and anastomotic leakage in 3.5%. Median length of stay was 3.0 days (1-69), single-port success rate was 64.7%, and 15.3% was converted to an open procedure. CONCLUSION: This study confirms the safety, feasibility, and the advantages of SPRLC. In centers with adequate laparoscopic experienced surgeons, this technique should be considered as a serious and attractive alternative to restore intestinal continuity in patients with left-sided end colostomy, especially in patients after open index surgery. More research must be done in a multicenter setting to evaluate the use and standardization of single-port technique in reversal of intestinal continuity procedures.

Reversal of Hartmann's procedure utilizing single-port laparoscopy: an attractive alternative to laparotomy.

BACKGROUND: Complications after restoration of intestinal continuity (RIC) following Hartmann's procedure occur frequently and are often serious. These complications result in a reported morbidity of 4-30 % and a reported mortality of 10-14 %. Reducing the amount of surgical trauma accompanying abdominal access seems an attractive tool to reduce perioperative morbidity. This possibility is offered by single-port Hartmann's reversal (SPHR) through the colostomy site. METHODS: The purpose of the present prospective study was to compare outcome of SPHR to a retrospectively collected historical control group of conventional open Hartmann's reversal (OHR). All patients undergoing RIC between January 1, 2009, and January 1, 2014, were included in the present study. Operation time, morbidity and hospital stay were assessed. Postoperative surgical results of SPHR and OHR were the main outcome of the study. RESULTS: During the study period, 41 patients (M/F = 23:18; median age 58 (26-85) years) were included in the present study. Sixteen patients underwent OHR; 25 patients underwent SPHR. No mortality was observed in the present series. Median operation time was similar between groups [184 (29-377) vs. 153.5 (73-332) min]. Hospital stay was significantly shorter in the SPHR group [16 (4-74) vs. 4 (1-34) days, p < 0.05]. The number of complications was significantly lower in the SPHR group (33 vs. 10, p < 0.05); furthermore, significantly less patients had severe complications (Clavien-Dindo III or higher) in the SPHR group (7/33 vs. 1/10). Less wound-related complications occurred in the SPHR group (12 vs. 5, p < 0.05). CONCLUSION: This study confirms recent findings in the literature regarding the safety and feasibility of SPHR. SPHR seems to be an attractive alternative to OHR.

Development of a composite endpoint for randomized controlled trials in pancreaticoduodenectomy.

BACKGROUND: Few randomized controlled trials (RCTs) have been performed in patients undergoing pancreaticoduodenectomy (PD). An important factor contributing to this is the large number of patients needed to adequately power RCTs for relevant clinical single endpoints. A PD-specific composite endpoint (CEP) could solve this problem. The aim of the present study was to develop a PD-specific CEP, consisting of complications related to PD, allowing reduction in sample sizes and improving the ability to compare outcomes. METHODS: PD-specific CEP components were selected after a systematic review of the literature and consensus between 25 international pancreatic surgeons. Ultimately, prospective cohorts of patients who underwent PD in two high-volume HPB centers (London, UK, and Maastricht, NL) were used to assess the event rate and effect of implementing a PD-specific CEP. RESULTS: From a total of 18 single-component endpoints, intra-abdominal abscess, sepsis, post-PD hemorrhage, bile leakage, gastrojejunostomy leakage, leakage of the pancreatic anastomosis, delayed gastric emptying, and operative mortality within 90 days were selected to be included the PD-specific CEP. All eight components had consensus definitions and a Dindo-Clavien classification of 3 or more. The incidence of the PD-specific CEP was 24.7 % in the Maastricht cohort and 23.3 % in the London cohort. These incidence rates led to a twofold reduction in the theoretical calculated sample size for an adequately powered RCT on PD using this CEP as a primary endpoint. CONCLUSIONS: The proposed PD-specific CEP enables clinical investigators to adequately power RCTs on PD and increases the feasibility, comparability, and utility in meta-analysis.

Comparative Quality of Life in Patients Following Transanal Minimally Invasive Surgery and Healthy Control Subjects.

BACKGROUND: Transanal minimally invasive surgery (TAMIS) is considered the successor of transanal endoscopic microsurgery (TEMS). It makes use of more readily available laparoscopic instruments and single-port access platforms with similar perioperative, clinical and oncological outcomes. Little is known about quality of life (QoL) outcomes after the use of TAMIS. The aim of this study was to assess QoL after TAMIS in our patients and compare this with QoL in the healthy Dutch population. METHODS: All patients undergoing TAMIS for selected rectal neoplasms between October 2011 and March 2014 were included in this analysis. Patients were studied for a minimal period of 24 months. QoL outcomes were measured using the Short-Form 36 Health Survey (SF-36) questionnaire; faecal continence was measured using the Faecal Incontinence Severity Index questionnaire. Patient reported outcomes were compared to case-matched healthy Dutch control subjects. We hypothesise that undergoing TAMIS will subsequently result in a decreased quality of life in patients compared to healthy individuals. RESULTS: Thirty-seven patients (m:f = 17:20, median 67 years) were included in the current analysis. In four patients (10.8%), postoperative complications occurred. The median follow-up was 36 (range 21-47) months. Postoperative QoL scores are similar comparable to those reported by Dutch healthy controls. Patients reported a statistically significant better QoL score in the 'bodily pain' domain when compared to the controls (81.8 vs. 74.1 points) (p = 0.01). Significant worse QoL scores for the 'social functioning' domain were reported by patients after TAMIS (84.4 vs. 100 points) (p = 0.03). CONCLUSION: TAMIS seems to be a safe technique with postoperative QoL scores similar to that of healthy case matched controls in 3-year follow-up. There seems to be no association between faecal incontinence and reported QoL. Negative effects of TAMIS on social functioning of patients should not be underestimated and should be discussed during preoperative counselling.