Moxibustion for Managing Postoperative Urinary Retention After Hemorrhoidectomy and Anorectal Surgeries: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PURPOSE: Common surgical procedures for conditions affecting the anus and rectum such as hemorrhoidectomy are associated with high risks of postoperative urinary retention (POUR). Little is known about the efficacy of moxibustion in managing POUR after such surgical procedures. This systematic review and meta-analysis aimed to review the related literature and synthesize data on the effectiveness of moxibustion in managing POUR after common anorectal surgeries. DESIGN: A systematic review and meta-analysis of randomized controlled trials (RCTs). METHODS: PubMed, EMBASE, CENTRAL, Chinese National Knowledge Infrastructure (CNKI), VIP information, and Wanfang databases were searched to October 1, 2021 using the keywords urinary retention, moxibustion, and moxa. Randomized controlled trials (RCTs) investigating patients who had developed POUR after hemorrhoidectomy or other anorectal surgeries were eligible for inclusion. Patients receiving moxibustion formed the intervention group and the control group received usual care alone. Primary outcomes were markedly effective rate, defined as spontaneous voiding with complete symptom relief within 30 to 60 minutes after treatment; and total effective rate (ie, markedly effective rate plus effective rate, defined as spontaneous voiding with partial relief of symptoms within 60 minutes to 4 hours after treatment). Secondary outcome was time to first urination after treatment. FINDINGS: Thirty-four RCTs met the eligibility criteria. Pooled analysis revealed that the markedly effective rate was significantly higher in the moxibustion group than that in the control group (pooled RR = 2.53, 95% CI = 2.17-2.95), and the total effective rate in the moxibustion group was also higher than that in the control group (pooled RR = 5.02, 95% CI = 4.01-6.28). The intervention group had significantly shorter times to first urination than controls (pooled effect = -2.81, 95% CI = -2.06 to -3.56). CONCLUSIONS: Moxibustion appears superior to usual care in relieving POUR after common anorectal surgeries. Future studies are still warranted to confirm these findings.

Pain assessment following open hemorrhoidectomy under local anesthesia versus saddle block: a multicenter randomized controlled trial.

BACKGROUND: There is disparity in evidence on pain assessment post open hemorrhoidectomy (OH) using local anesthesia and its use in developing countries compared to developed countries. Therefore, we conducted this study to assess the occurrence of postoperative pain following open hemorrhoidectomy under local anesthesia versus saddle block for uncomplicated 3rd or 4th degree hemorrhoids. METHODS: This was a prospective equivalence randomized, double blind controlled trial conducted from December 2021 to May 2022 among patients with primary uncomplicated 3rd or 4th degree hemorrhoids. Pain severity was assessed at 2, 4 and 6 h post open hemorrhoidectomy using visual analogue scale (VAS). Data was analysed using SPSS version 26 at a p < 0.05 as statically significant using visual analogue scale (VAS). RESULTS: We recruited 58 participants in this study who underwent open hemorrhoidectomy under local anesthesia or saddle block (29 participants per group). The sex ratio was of 1.15 of female to male and a mean age of 39 ± 13. VAS was found to be different at 2 h post OH compare to other time of pain assessment but not statically significant by area under the cover (AUC) (95% CI = 486-0.773: AUC = 0.63; p = 0.09) with a none significance by Kruskal-Wallis's test (p:0.925). CONCLUSION: Local anesthesia was found to be having a similar pain severity occurrence in post operative period among patients undergoing open hemorrhoidectomy for primary uncomplicated 3rd or 4th degree hemorrhoids. Close monitoring of pain in postoperative period is mandatory especially at 2 h to assess need of analgesia. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR202110667430356. Registered on 8th October, 2021.

Open hemorrhoidectomy under local anesthesia versus saddle block in western Uganda: a study protocol for a prospective equivalence randomized, double-blind controlled trial.

BACKGROUND: While open hemorrhoidectomy under local anesthesia has been shown to be more cost-effective with shorter operation times and lower complication rates, local anesthesia is still not considered as a first-line technique in low-income countries like Uganda. The objective of this trial is to compare open hemorrhoidectomy using local anesthesia versus saddle block among patients with primary uncomplicated 3rd- or 4th-degree hemorrhoids in western Uganda. METHODS: The protocol for a prospective equivalence randomized, double-blind controlled trial was conducted among patients with primary uncomplicated 3rd- or 4th-degree hemorrhoids. Recruitment was started in December 2021 and is expected to end in May 2022. Consenting participants who require open hemorrhoidectomy indicated at Kampala International Teaching Hospital, Uganda, will be randomized into two groups of 29 patients per arm. DISCUSSION: The primary outcome of this study is to compare the occurrences of postoperative pain following open hemorrhoidectomy using the visual analog scale in an interval of 2, 4, and 6 h and 7 days postoperatively. Furthermore, the mean operative time from the induction of anesthesia to the end of the surgical procedure as well as the cost-effectiveness of the 2 techniques will be assessed in both groups. Open hemorrhoidectomy under local anesthesia has the potential to offer benefits to patients but most importantly expediting return to baseline and functional status, shorter hospital stay by meeting the faster discharge criteria, and reduction in costs associated with reduced length of stay and complications. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202110667430356. Registered on 8 October 2021.

The Effect of Perianal Tramadol Infiltration on Postoperative Pain Following Hemorrhoidectomy.

INTRODUCTION: The present study was attempted to evaluate the effect of perianal infiltration of tramadol on postoperative pain in patients undergoing hemorrhoidectomy. METHOD: This double-blind clinical trial study was carried out on 90 patients with grade 3 and 4 hemorrhoids undergoing hemorrhoidectomy. Patients were randomly assigned into 3 groups of control or bupivacaine or tramadol. Before the surgery, perianal infiltration of .25% bupivacaine or tramadol or normal saline was prescribed to each group, respectively. Data on pain severity (based on the visual analog scale (VAS), the duration of surgery, sedation score, pain at the first defecation, first request time for additional analgesia, nausea and vomiting, and analgesic intakes) were evaluated and analyzed. RESULTS: Duration of surgery was almost similar in all 3 groups (P = .974). The results showed a significant difference in pain score between 3 groups (P ≤.05) at all times after the surgery. In addition, the means of sedation scores (P = .03), pain score at the first defecation (P = .001), the time to first analgesic request (P = .001), and ketorolac administration times (P = .01) were significantly different between 3 groups. Finally, no complication was reported regarding postoperative nausea and vomiting. CONCLUSION: Given the notable efficacy of tramadol in reducing pain after hemorrhoidectomy and its minor side effects, this medication is suggested as an effective topical anesthetic to decrease pain after hemorrhoidectomy.

Interventional treatments for prolapsing haemorrhoids: network meta-analysis.

BACKGROUND: Multiple treatments for early-moderate grade symptomatic haemorrhoids currently exist, each associated with their respective efficacy, complications, and risks. The aim of this study was to compare the relative clinical outcomes and effectiveness of interventional treatments for grade II-III haemorrhoids. METHODS: A systematic review was conducted according to PRISMA criteria for all the RCTs published between 1980 and 2020; manuscripts were identified using the MEDLINE, Embase, and CENTRAL databases. Inclusion criteria were RCTs comparing procedural interventions for grade II-III haemorrhoids. Primary outcomes of interest were: symptom recurrence at a minimum follow-up of 6 weeks, postprocedural pain measured on a visual analogue scale (VAS) on day 1, and postprocedural complications (bleeding, urinary retention, and bowel incontinence). After bias assessment and heterogeneity analysis, a Bayesian network meta-analysis was performed. RESULTS: Seventy-nine RCTs were identified, including 9232 patients. Fourteen different treatments were analysed in the network meta-analysis. Overall, there were 59 RCTs (73 per cent) judged as being at high risk of bias, and the greatest risk was in the domain measurement of outcome. Variable amounts of heterogeneity were detected in direct treatment comparisons, in particular for symptom recurrence and postprocedural pain. Recurrence of haemorrhoidal symptoms was reported by 54 studies, involving 7026 patients and 14 treatments. Closed haemorrhoidectomy had the lowest recurrence risk, followed by open haemorrhoidectomy, suture ligation with mucopexy, stapled haemorrhoidopexy, and Doppler-guided haemorrhoid artery ligation (DG-HAL) with mucopexy. Pain was reported in 34 studies involving 3812 patients and 11 treatments. Direct current electrotherapy, DG-HAL with mucopexy, and infrared coagulation yielded the lowest pain scores. Postprocedural bleeding was recorded in 46 studies involving 5696 patients and 14 treatments. Open haemorrhoidectomy had the greatest risk of postprocedural bleeding, followed by stapled haemorrhoidopexy and closed haemorrhoidectomy. Urinary retention was reported in 30 studies comparing 10 treatments involving 3116 participants. Open haemorrhoidectomy and stapled haemorrhoidopexy had significantly higher odds of urinary retention than rubber band ligation and DG-HAL with mucopexy. Nine studies reported bowel incontinence comparing five treatments involving 1269 participants. Open haemorrhoidectomy and stapled haemorrhoidopexy had the highest probability of bowel incontinence. CONCLUSION: Open and closed haemorrhoidectomy, and stapled haemorrhoidopexy were associated with worse pain, and more postprocedural bleeding, urinary retention, and bowel incontinence, but had the lowest rates of symptom recurrence. The risks and benefits of each treatment should be discussed with patients before a decision is made.

Haemorrhoidectomy under local anaesthesia versus spinal anaesthesia: a systematic review and meta-analysis.

AIMS: To evaluate comparative outcomes of local anaesthesia (LA) and spinal anaesthesia (SA) in patients undergoing haemorrhoidectomy. METHODS: A systematic online search was conducted using the following databases: PubMed, Scopus, Cochrane Database, The Virtual Health Library, Clinical trials.gov , and Science Direct. Only randomised controlled trials (RCTs) comparing excisional haemorrhoidectomy under LA and SA were included. Post-operative pain score, need for rescue analgesia, urinary retention, headache, rectal bleeding, and operative time were the evaluated outcome parameters. RESULTS: Seven RCTs reporting a total number of 440 patients of whom 222 patients underwent haemorrhoidectomy under LA and 218 patients had the procedure under SA were included. LA was associated with significantly lower post-operative pain at 6 h (mean difference (MD) - 2.25, P = 0.0001) and at 24 h (MD - 0.87, P = 0.0002), need for a rescue analgesia (risk ratio (RR) 0.18, P = 0.002), urinary retention (RR 0.17, P = 0.0001), and headache (RR 0.09, P = 0.0003) compared with SA. However, there was no significant difference in rectal bleeding (RR 0.89, P = 0.70) and operative time (MD 1.15, P = 0.19) between LA and SA. CONCLUSION: Compared with SA, LA may be associated with significantly lower post-operative pain, need for rescue analgesia, urinary retention, and headache making it an attractive choice of anaesthesia in day-case surgery for those who are not either fit for GA or refuse such anaesthetic modality.

Effects of the pestle needle therapy, a type of acupoint stimulation, on post-hemorrhoidectomy pain: A randomized controlled trial.

BACKGROUND: Hemorrhoids are one of the most common conditions that lead to surgery, and until now surgical hemorrhoidectomy has been the major effective treatment. Post-operative pain from hemorrhoidectomy has been experienced by thousands of patients and remains a major inconvenience of the operation. OBJECTIVE: This study evaluates the clinical efficacy of the pestle needle therapy, an acupoint stimulation method, for relief of post-hemorrhoidectomy pain. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This was a single-center, patient-assessor-blinded and randomized controlled trial with 154 patients receiving Milligan hemorrhoidectomy surgery. Eligible patients were randomly assigned to either a treatment group or a control group at a ratio of 1:1. The treatment group received the pestle needle therapy, with manual stimulation at Yaoshu (DU2), Mingmen (DU4), Changqiang (DU1), Chengshan (BL57), Erbai (EX-UE2) and the perianal points (1, 3, 5, 7, 9, and 11o'clock around the lesion); while the control group received a sham treatment with very light pressure. Three sessions of treatment were performed at 30 min, 4 h and 12 h after the surgery, and each lasted for 15 min. MAIN OUTCOME MEASURES: The primary outcome was post-operative pain measured with the visual analogue scale (VAS) at 12 h after surgery. The secondary outcomes included the VAS scores measured at 0.5, 2, 4, 6, 8, 24 and 48 h after surgery, the analgesic dose, the time and the VAS score of the patients' first defecation after surgery, as well as the Hamilton Rating Scale for Anxiety (HAMA) evaluated before discharge. RESULTS: The mean pain score of the treatment group was significantly lower than that of the control group (3.10 ± 1.27 vs 4.82 ± 1.29; P < 0.001) at 12 h after surgery. Compared with the control group, patients in the treatment group needed a smaller dose of analgesic within the first 24 hours after surgery (P = 0.002); and their HAMA scores before discharge were lower (4.07 ± 2.40 vs 5.10 ± 2.45, P = 0.009). Compared to the treatment group, patients in the control group had a greater time to the first defecation after surgery ([52.34 ± 15.72] h vs [27.08 ± 13.68] h; P < 0.001), but there was no difference in their VAS scores at the first defecation (P = 0.092). CONCLUSION: The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.

Comparison of Centella with Flavonoids for Treatment of Symptoms in Hemorrhoidal Disease and After Surgical Intervention: A Randomized Clinical Trial.

Phlebotonics' effects were evaluated to reduce time-to-stop bleeding and anal irritation in 130 patients who complained of hemorrhoidal disease (HD); bleeding and pain after hemorrhoidectomy (31 patients) and hemorrhoidal thrombosis (34 patients) in the short time. Sixty patients were randomized to receive the routine treatment (both conservative and surgical) (control Group C). The treated group (both conservative and surgical) was divided into two subgroups: one treated with flavonoids (Group A, n = 73), the other with Centella (Group B, n = 66). Time-to-stop bleeding was checked at baseline and checkups (0 up to day 42). Healing was estimated with Kaplan-Meier method, the Kruskal-Wallis test estimated changes in the VAS scores. The HD median time-to-stop bleeding was 2 weeks for Groups A and B; 3 weeks for Group C. VAS scores comparison among Groups (irritation): A vs C, p = 0.007; B vs C, p = 0.041; and A vs B, p = 0.782 resulted respectively. As for operated hemorrhoids, the time-to-stop bleeding was 3 and 4 weeks in Groups A and B and 5 in Group C. Histopathology showed an association between flavonoids and piles' fibrosis (p = 0.008). Phlebotonics in HD, as well as after surgery, showed significant beneficial effects. Flavonoids are the most effective phlebotonics against bleeding and anal irritation.

Anorectal Functional Outcomes Following Doppler-Guided Transanal Hemorrhoidal Dearterialization: Evidence from Vietnam.

INTRODUCTION: Doppler-guided transanal hemorrhoidal dearterialization (THD) was considered a less invasive and innovative method to treat hemorrhoidal disease, but it may impact the anal area during dearterialization and mucopexy. Thus, this study aimed to assess any changes in anorectal manometry of grade III and IV hemorrhoidal patients following THD treatment. METHODS: This prospective observational study was conducted with patients who had grades III and IV hemorrhoidal disease. The patients were treated using THD at the Department of Surgery in the National Hospital of Traditional Medicine (Hanoi, Vietnam) between June 2012 and December 2013. Anorectal manometry was performed prior to THD and again between 6 and 12 months following the procedure. RESULTS: A total of 40 patients were enrolled in the study, including 32 with grade III hemorrhoids and 8 with grade IV hemorrhoids. The proportion of male patients (65%) was higher than that of female patients (35%), and the majority of patients (82.5%) were > 40 years old. The mean duration of symptoms prior to treatment was 12.3 years. The mean length of the anal sphincter was unchanged before and after THD (3.64 ± 0.40 cm prior to treatment vs. 3.66 ± 0.48 cm following treatment; p = 0.57). Significant differences in treatment-related changes were detected for all anorectal manometric measurements except maximum squeezing pressure (p < 0.05). No patient showed anal stenosis or fecal incontinence. CONCLUSION: The THD technique did not change the length of the anal sphincter 6 months after hemorrhoid treatment. The values of anal pressure and rectal sensation decreased almost significantly between treatment and the follow-up visit. We suggest that further studies, which include larger sample sizes, should be conducted to confirm THD effectiveness in terms of anorectal functions.

Randomized clinical study on the analgesic effect of local infiltration versus spinal block for hemorrhoidectomy.

BACKGROUND AND OBJECTIVES:: Postoperative analgesia and early recovery are important for hospital discharge. The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare time to discharge, adverse effects and complications. DESIGN AND SETTING:: Randomized, prospective and comparative study at Dr. Mário Gatti Hospital. METHODS:: Forty patients aged 18-60, in American Society of Anesthesiologists physical status category 1 or 2, were included. The local group (LG) received local infiltration (0.75% ropivacaine) under general anesthesia; the spinal group (SG) received subarachnoid block (2 ml of 0.5% bupivacaine). Analgesic supplementation consisted of fentanyl for LG and lidocaine for SG. Postoperative pain intensity, sphincter relaxation, lower-limb strength, time to discharge, analgesic dose over one week and adverse effects were assessed. RESULTS:: Eleven LG patients (52.4%) required supplementation, but no SG patients. Pain intensity was higher for LG up to 120 min, but there were no differences at 150 or 180 min. There were no differences in the need for paracetamol or tramadol. Times to first analgesic supplementation and hospital discharge were longer for SG. The adverse effects were nausea, dizziness and urinary retention. CONCLUSIONS:: Pain intensity was higher in LG than in SG over the first 2 h, but without differences after 150 and 180 min. Time to first supplementation was shorter in LG. There were no differences in doses of paracetamol and tramadol, or in adverse effects. REGISTRATION:: ClinicalTrials.gov NCT02839538.

Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Two commonly performed surgical interventions are available for severe (grade II-IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery. METHODS: The eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II-IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. FINDINGS: Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference -0·073 (95% CI -0·140 to -0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled haemorrhoidopexy group. 24 (7%) of 338 participants who received stapled haemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. INTERPRETATION: As part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice. FUNDING: National Institute for Health Research Health Technology Assessment programme.

A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

BACKGROUND: Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. METHODS/DESIGN: eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. DISCUSSION: This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and, more importantly, patients can make informed choices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).

Use of gracilis muscle as a "walking" flap for repair of a rectovaginal fistula.

Rectovaginal fistula is a rare but debilitating complication of a variety of pelvic operations. Management remains challenging with high incidence of failure. The majority of patients eventually require surgical intervention. Several surgical procedures have been described including local repair, muscle transposition, or laparotomy. Among the muscles used for rectovaginal fistula repair, the gracilis muscle interposition flap is an excellent option. However, in a small percentage of cases it fails, and alternative techniques should be entertained. We describe the case of a 50-year-old female who underwent stapled hemorrhoidopexy that was complicated by a 30 mm rectovaginal fistula, and required fecal diversion. Four months later, gracilis muscle interposition flap was performed but failed. The right gracilis flap was then re-used successfully as a "walking" flap. At three months the patient underwent closure of the temporary loop ileostomy, and continues to do well with no evidence of rectovaginal fistula recurrence one year later. To our knowledge, this is the first report of the use of a gracilis muscle as a "walking" flap for repair of a rectovaginal fistula, and should be considered as an alternative appropriate treatment for persistent rectovaginal fistulas after failure of initial gracilis muscle interposition flap.