This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores
Continuous recruitment of symptomatic internal hemorrhoid patients who visited the main center and sub centers was conducted using a stratified block randomization method, with a 1:1 random allocation to the endoscopic injection sclerotherapy group and endoscopic band ligation group for intervention. During the perioperative period, demographic characteristics, intraoperative conditions, postoperative complications and surgery related costs, length of hospital stay were recorded, and HDSS, EQ-5D-5L, EQ-VAS scores were recorded. Changes in scores were recorded during telephone follow-up at 2 weeks, 3 months, and 12 months after surgery, as well as whether the patient's symptoms improved, recurred, and satisfaction was assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
984
Patients were randomized assigned to the EIS group, preparing disposable endoscopic injections and sclerosing which were routinely administered with 1% polycinol.The transparent cap was fixed at the front end of the endoscope in inverted or orthofield of view.The stiffening agent or foam stiffer added to Meilan was injected with a disposable injection needle at 4-6 points at the oral end near the dentate line. Each point contained 0.2-1ml, and stopped after the hemorrhoid nucleus changed color. If necessary, a transparent cap was pressed to stop the bleeding to distribute the stiffening agent evenly.
Patients were randomized assigned to the EBL group and were to be prepared before surgery.After the socket is mounted at the inner lens end, the socket is obviously tied at 1-2cm hemorrhoids at the mouth above the dentate line, usually 2-4 rings.With mucosal prolapse, pericyclic multiple dislocation ligation can be performed 2-3cm above the obvious prolapse.
Mingkai Chen
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
recurernce rate
After treatment, the recurrence of internal hemorrhoids symptoms
Time frame: 12 months after surgery
Postoperative complications and adverse events
Patients from complications and adverse events following intervention (postoperative bleeding, anal distension, pain, urinary retention and others)
Time frame: Postoperative and follow-up periods
early symptom relief rates
self-rated improvement postoperative 2 weeks and 3 months
Time frame: 2 weeks and 3 months after surgery
HDSS
Hemorrhoid Disease Symptom Score， scale 0-20, high score means better
Time frame: 2 week, 3 month, 12 month after surgery
EQ-5D-5L
the European Quality of Life 5-Dimensions 5-Levels questionnaire, scale -1 \~ 1, high scores means better outcome
Time frame: 2 week, 3 month, 12 month after surgery
EQ-VAS
the European Quality of visual analogue scale, scale 0-100, high value means better
Time frame: 2 week, 3 month, 12 month after surgery
Surgical costs
Cost of treatment
Time frame: After surgery
Patient satisfaction survey
Patient satisfaction evaluation of the treatment method
Time frame: 3 months or 12 months after surgery
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